FDA Adverse Event
Malfunction
Summary report: N
PILLOW, GEL INFANT POSITIONING AID 6INX9IN
MDR report key: 1182660
·
Received September 21, 2008
Report
- Report Number
- 1182660
- Event Type
- Malfunction
- Date Received
- September 21, 2008
- Date of Event
- August 8, 2008
- Report Date
- September 21, 2008
- Manufacturer
- HAWAII MEDICAL, LLC
- Product Code
- FRP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
GEL PILLOW FOUND TO BE LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PILLOW, GEL INFANT POSITIONING AID 6INX9IN | PAD, GEL | FRP | HAWAII MEDICAL, LLC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 MO |