MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2015-09-25 for DUODERM H/ACTIVE GEL 15G 187990 manufactured by Convatec Limited.
[26788488]
Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro. Convatec is submitting this report pursuant to the provisions of 21cfr part 803. Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
Patient Sequence No: 1, Text Type: N, H10
[26788489]
It was reported that the aluminum security seal of tube was broken inside the sealed box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2015-30076 |
| MDR Report Key | 5104996 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2015-09-25 |
| Date of Report | 2014-02-27 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2009-07-10 |
| Date Added to Maude | 2015-09-25 |
| 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 | JEANETTE JOHNSON |
| Manufacturer Street | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3362973009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUODERM H/ACTIVE GEL 15G |
| Generic Name | DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC |
| Product Code | NAE |
| Date Received | 2015-09-25 |
| Model Number | 187990 |
| Lot Number | 9G44839 |
| Device Expiration Date | 2012-07-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH52NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-25 |