MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-08-31 for DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING 187990 manufactured by Convatec Ltd.
[119034846]
(b)(6). Product was returned. One tube of duoderm hydroactive gel 15g, unused. The tube did appear popped based on visual inspection. Product will be kept until investigation phase completion. Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. Fda registration number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119034847]
It was reported the "side of the tube popped up and cracked". Photos have been received depicting the reported complaint issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2018-00082 |
| MDR Report Key | 7838216 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-08-31 |
| Date Mfgr Received | 2018-10-09 |
| Date Added to Maude | 2018-08-31 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer G1 | CONVATEC LTD |
| Manufacturer Street | FIRST AVENUE DEESIDE INDUSTRIAL PARK |
| Manufacturer City | DEESIDE, FLINTSHIRE CH5 2NU |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CH5 2NU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING |
| Generic Name | DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC |
| Product Code | NAE |
| Date Received | 2018-08-31 |
| Returned To Mfg | 2018-08-13 |
| Model Number | 187990 |
| Lot Number | 7H03213 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LTD |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH5 2NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-31 |