MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-09-22 for P.A.P. PLAGIOCEPHALY APPLIED PRESSURE ORTHOSIS manufactured by Personal Performance Medical Corp..
[17466477]
An infant passed away while wearing the p. A. P. Orthosis.
Patient Sequence No: 1, Text Type: D, B5
[17638215]
The helmet is still in the property of the parents and has not been inspected by the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003603920-2010-00001 |
| MDR Report Key | 1846224 |
| Report Source | 06 |
| Date Received | 2010-09-22 |
| Date of Report | 2010-09-16 |
| Date of Event | 2010-08-31 |
| Date Facility Aware | 2010-09-07 |
| Report Date | 2010-09-16 |
| Date Reported to FDA | 2010-09-20 |
| Date Reported to Mfgr | 2010-09-16 |
| Date Mfgr Received | 2010-09-16 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2010-09-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Phone | 8013643100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | P.A.P. PLAGIOCEPHALY APPLIED PRESSURE ORTHOSIS |
| Generic Name | CRANIAL HELMET |
| Product Code | MVA |
| Date Received | 2010-09-22 |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERSONAL PERFORMANCE MEDICAL CORP. |
| Manufacturer Address | SALT LAKE CITY UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-09-22 |