MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-21 for DUODERM? HYDROACTIVE? GEL, STERILE- 30 GRAMS 187987 manufactured by Convatec Limited.
[58523491]
Expiration date - 09/2018. Device manufacture date - 09/2015. Based on the available information, this event is deemed to be a reportable malfunction. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4). Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[58523492]
It was reported the tube present cracks during use, therefore it is difficult to use the full content of the product. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
[61004600]
A batch record review indicates no discrepancies however the labour sheets confirm tube jams and dents during manufacturing of the associated batch. Product maintenance was completed to schedule. There were no issues relating to the reported complaint in the machine logs. Additional training requirements were identified. A nonconformance has been initiated to further investigate the issue. The complaint will remain open until the investigation is approved and complete. This issue will be monitored through the post market product monitoring review process. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000317571-2016-00084 |
| MDR Report Key | 6046283 |
| Date Received | 2016-10-21 |
| Date of Report | 2016-10-05 |
| Date of Event | 2016-10-04 |
| Date Mfgr Received | 2016-10-26 |
| Date Added to Maude | 2016-10-21 |
| 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 | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUODERM? HYDROACTIVE? GEL, STERILE- 30 GRAMS |
| Generic Name | DRESSING, WOUND,HYDROGEL W/OUT DRUG |
| Product Code | NAE |
| Date Received | 2016-10-21 |
| Model Number | 187987 |
| Lot Number | 5J01183 |
| 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 CH5 2NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-21 |