MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-21 for PILLOW, GEL INFANT POSITIONING AID 6INX9IN 333-102007 manufactured by Hawaii Medical, Llc.
[21281483]
Gel pillow found to be leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1182660 |
| MDR Report Key | 1182660 |
| Date Received | 2008-09-21 |
| Date of Report | 2008-09-21 |
| Date of Event | 2008-08-08 |
| Report Date | 2008-09-21 |
| Date Reported to FDA | 2008-09-21 |
| Date Added to Maude | 2008-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLOW, GEL INFANT POSITIONING AID 6INX9IN |
| Generic Name | PAD, GEL |
| Product Code | FRP |
| Date Received | 2008-09-21 |
| Returned To Mfg | 2008-08-29 |
| Model Number | NA |
| Catalog Number | 333-102007 |
| Lot Number | NA |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 1213263 |
| Manufacturer | HAWAII MEDICAL, LLC |
| Manufacturer Address | 750 CORPORATE PARK PEMBROKE MA 02359 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-21 |