MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-21 for GEL-E DONUT manufactured by Philips/respironics.
[4443272]
Product was removed from original packaging and noted to have black mold growing on it. A new product was removed from same box and noted to have same problem, all except for 2 of these in this same box were noted to have mold on them. All products "best used by" date is 11-2004. Products were kept sealed in plastic from mfr, in mfr's original box in a clean, dry location in the nursery and not respond to light or excessive temperatures. Diagnosis or reason for use: indicated as a head support or positioning air for newborns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035755 |
| MDR Report Key | 3770946 |
| Date Received | 2014-04-21 |
| Date of Report | 2014-04-19 |
| Date of Event | 2014-04-19 |
| Date Added to Maude | 2014-04-25 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | GEL-E DONUT |
| Product Code | FMP |
| Date Received | 2014-04-21 |
| Lot Number | 92025-C |
| Device Expiration Date | 2014-11-20 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS/RESPIRONICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-21 |