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 2015-09-24 for VARIHESIVE GEL W/NZL 401802 manufactured by Convatec Limited.
[26605375]
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4). 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). Evaluation conclusions are reflected in the codes.
Patient Sequence No: 1, Text Type: N, H10
[26605377]
It was reported that "brown gel was attached on a cap. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2015-30180 |
| MDR Report Key | 5100059 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-09-24 |
| Date of Report | 2014-02-27 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2011-08-26 |
| Date Added to Maude | 2015-09-24 |
| 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 | VARIHESIVE GEL W/NZL |
| Generic Name | DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC |
| Product Code | NAE |
| Date Received | 2015-09-24 |
| Returned To Mfg | 2013-02-26 |
| Model Number | 401802 |
| Lot Number | 1H00404 |
| Device Expiration Date | 2014-08-01 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-09-24 |