DeathMVA
P.A.P. PLAGIOCEPHALY APPLIED PRESSURE ORTHOSIS
Received Sep 22, 2010 · Event occurred Aug 31, 2010
Report 3003603920-2010-00001 · MDR key 1846224
Device
Generic name
Cranial Helmet
Manufacturer
Personal Performance Medical Corp.Product problems
- Insufficient Device Problem Information
Patient
5 MO
- Death
Narrative
Description of Event or Problem
AN INFANT PASSED AWAY WHILE WEARING THE P.A.P. ORTHOSIS.
Additional Manufacturer Narrative
THE HELMET IS STILL IN THE PROPERTY OF THE PARENTS AND HAS NOT BEEN INSPECTED BY THE MANUFACTURER.