MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-16 for DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING 187990 manufactured by .
[105665637]
No complainant street address, postal code or phone number was provided. (b)(6). 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. ?
Patient Sequence No: 1, Text Type: N, H10
[105665638]
It was reported the tube was opened. Additional information received stating that the? Security seal that covers the product under normal conditions was not found. So, the product was with the lid but without seal.? A photograph was provided depicting the reported complaint issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2018-00054 |
| MDR Report Key | 7433909 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-16 |
| Date of Event | 2018-03-26 |
| Date Mfgr Received | 2018-06-27 |
| Date Added to Maude | 2018-04-16 |
| 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 |
| 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 | 2018-04-16 |
| Model Number | 187990 |
| Lot Number | 7F00261 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-16 |