MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING 187987 manufactured by .
[95919879]
(b)(6). 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
[95919880]
It was reported that there was a hole in the tube base of the duoderm hydroactive gel product. A photo depicting the reported complaint issue was provided by the complainant. No further details have been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2017-00076 |
| MDR Report Key | 7133794 |
| Date Received | 2017-12-20 |
| Date of Event | 2017-12-12 |
| Date Mfgr Received | 2018-02-19 |
| Date Added to Maude | 2017-12-20 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| 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 | 2017-12-20 |
| Model Number | 187987 |
| Lot Number | 7B02112 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-20 |