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 |