RE: [SPAM] Question on Helmet risks?

[Guest guest]

If you read further in the document it mentions that there are special controls to address the risks and provide reasonable assurance of the safety and effectiveness of the device. Specifically it says:“evaluate device fit and to describe the steps that should be taken in order to reduce the potential for restriction of cranial growth, the possible impairment of brain growth and development and skin irritation and/or breakdown”

Molly

Novato, California

Nicolas, 2.5, tort & plagio, STARband (CIRS Oakland)

4/24/06-9/12/06, Graduate!

, 5

, 8.5

From: Plagiocephaly

[mailto:Plagiocephaly ] On Behalf Of Miranda

Sent: 9 May 2008 01:13

plagiocephaly

Subject: [sPAM] Question on Helmet risks?

Hello All,

I am new to this group. My daughter is diagnosed with a mild plagio. There is a

little facial asymmetry too associated with the plagio which I am concerned

about. I have researching about the helmet and I found the FDA approval for

this device at:

http://www.cranialtech.com/FDA_approval.html

There is paragraph in the approval on the risks and the third risk about

impairment of brain growth really got me worried. I wanted to know what the

mother's with experience think about this.

With a mild plagio its so difficult to decide whether to opt for the helmet or

not..

----Snippet----

FDA identified the following risks to health associated with this

type of device: (1) Skin irritation, skin breakdown and subsequent

infection due to excessive pressure on the skin; (2) head and neck

trauma due to alteration of the functional center of mass of the head

and the additional weight of the device especially with an infant who

is still developing the ability to control his/her head and neck

movements; (3) impairment of brain growth and development from

mechanical restriction of cranial growth; (4) asphyxiation due to

mechanical failure, poor fit, and/or excessive weight that alters the

infant's ability to lift the head; (5) eye trauma due to mechanical

failure, poor construction and/or inappropriate fit; and (6) contact

dermatitis due to the materials used in the construction of the device.

---Snippet----

Looking forward to your inputs,

Be a better friend, newshound, and know-it-all with

Mobile. Try

it now.

[Guest guest]

Thanks Molly. I am so glad you pointed it out.. I missed it totally in my first read. Thanks, "Foley, Molly" <mafoley@...> wrote: If you read further in the document it mentions that there are special controls to address the risks and provide reasonable assurance of the safety and effectiveness of the device. Specifically it says:“evaluate device fit and to describe the steps that should be taken in order to reduce the potential for restriction of cranial growth, the possible impairment of brain growth and development and skin irritation and/or breakdown” Molly Novato, California Nicolas, 2.5, tort & plagio, STARband (CIRS Oakland) 4/24/06-9/12/06, Graduate! , 5 , 8.5 From: Plagiocephaly [mailto:Plagiocephaly ] On Behalf Of MirandaSent: 9 May 2008 01:13plagiocephaly Subject: [sPAM] Question on Helmet risks? Hello All,I am new to this group. My daughter is diagnosed with a mild plagio. There is a little facial asymmetry too associated with the plagio which I am concerned about. I have researching about the helmet and I found the FDA approval for this device

at:http://www.cranialtech.com/FDA_approval.htmlThere is paragraph in the approval on the risks and the third risk about impairment of brain growth really got me worried. I wanted to know what the mother's with experience think about this.With a mild plagio its so difficult to decide whether to opt for the helmet or not..----Snippet----FDA identified the following risks to health associated with this type of device: (1) Skin irritation, skin breakdown and subsequent infection due to excessive pressure on the skin; (2) head and neck trauma due to alteration of the functional center of mass of the head and the additional weight of the device especially with an infant who is still developing the ability to control his/her head and neck movements; (3) impairment of brain growth and development from mechanical restriction of cranial growth; (4)

asphyxiation due to mechanical failure, poor fit, and/or excessive weight that alters the infant's ability to lift the head; (5) eye trauma due to mechanical failure, poor construction and/or inappropriate fit; and (6) contact dermatitis due to the materials used in the construction of the device. ---Snippet----Looking forward to your inputs, Be a better friend, newshound, and know-it-all with Mobile. Try it now.

Be a better friend, newshound, and know-it-all with Mobile. Try it now.