MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-24 for GEL-E DONUT - MEDIUM 92025-C manufactured by Philips Medical Systems.
[5269926]
The customer reported that the surgery department discovered 2 small black spots on product. There was no reported pt incident/injury.
Patient Sequence No: 1, Text Type: D, B5
[12511786]
(b)(4). Qty surgery department discovered 2 small black ports on it. There was no reported pt incident/injury. The 92025-c gel-e donut was evaluated. The 92025-c gel-e donut functioned as designed. Replacement 92025-c gel-e donut was ordered and shipped to the customer site. Returned 92025-c gel-e donut will be scraped after the eval has been completed. There was not a product malfunction, found to be performing as designed. No formal response was requested and none is warranted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2014-07323 |
| MDR Report Key | 4309744 |
| Report Source | 06 |
| Date Received | 2014-09-24 |
| Date of Report | 2014-08-25 |
| Date Mfgr Received | 2014-08-25 |
| Date Added to Maude | 2014-12-15 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEL-E DONUT - MEDIUM |
| Product Code | FMP |
| Date Received | 2014-09-24 |
| Returned To Mfg | 2014-09-04 |
| Model Number | 92025-C |
| Lot Number | USE BY DATE OF 2015-02-09 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-24 |