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.
[5192668]
The customer reported qty (02) surgery department discovered 2 small black spots on product. There was no reported pt incident/injury.
Patient Sequence No: 1, Text Type: D, B5
[12512138]
(b)(4). Qty (02) surgery department discovered 2 small black spots on product. There was no reported pt incident/injury. The 92025-c gel-e-donut was evaluated. The 92025-c gel-e-donut was found to be leaking above the letter "u" on the back side of the bladder. Replacement 92025-c-gel-e donuts were ordered and shipped to the customer site. There was a product malfunction (unrelated to mold). Found to be leaking above the letter "u" on the back side of the bladder. No formal response was requested and none is warranted.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1218950-2014-07321 |
MDR Report Key | 4309758 |
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 |