MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2014-09-08 for DUODERM MOISTURE RETENTIVE CFG DRESSING 187987 manufactured by Convatec Limited.
[4835042]
It was reported the protective seal was not present on the tube.
Patient Sequence No: 1, Text Type: D, B5
[12195307]
Based on the available information, this event is deemed to be a reportable malfunction. No additional information has been provided to date. No sample is expected to be returned. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000317571-2014-00078 |
| MDR Report Key | 4095516 |
| Report Source | 00,01,05,07 |
| Date Received | 2014-09-08 |
| Date of Report | 2014-08-21 |
| Date of Event | 2014-08-21 |
| Date Mfgr Received | 2014-08-21 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-09-24 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, DIRECTOR |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUODERM MOISTURE RETENTIVE CFG DRESSING |
| Generic Name | HYDROGEL WOUND AND BURN DRESSING |
| Product Code | NAE |
| Date Received | 2014-09-08 |
| Model Number | 187987 |
| Catalog Number | 187987 |
| Lot Number | 3H00023 |
| Device Expiration Date | 2016-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-08 |