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 |