FDA Adverse Event
Death
Summary report: N
P.A.P. PLAGIOCEPHALY APPLIED PRESSURE ORTHOSIS
MDR report key: 1846224
·
Received September 22, 2010
Report
- Report Number
- 3003603920-2010-00001
- Event Type
- Death
- Date Received
- September 22, 2010
- Date of Event
- August 31, 2010
- Report Date
- September 16, 2010
- Manufacturer
- PERSONAL PERFORMANCE MEDICAL CORP.
- Product Code
- MVA
- PMA / PMN Number
- K012804
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE HELMET IS STILL IN THE PROPERTY OF THE PARENTS AND HAS NOT BEEN INSPECTED BY THE MANUFACTURER.
Description of Event or Problem · 1
AN INFANT PASSED AWAY WHILE WEARING THE P.A.P. ORTHOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | P.A.P. PLAGIOCEPHALY APPLIED PRESSURE ORTHOSIS | CRANIAL HELMET | MVA | PERSONAL PERFORMANCE MEDICAL CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 MO | Death |