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 2019-12-19 for AQUACEL/AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESSING 403710 manufactured by Convatec Ltd.
[186555103]
A batch record review indicates no discrepancies. Preventive maintenance (pm) logs have been checked and pm's were completed. Aquacel ag 15x15cm was manufactured under system application products (sap) code 1139249 and manufacturing lot number 8f02207. Lot number 8f02207 was sterilized under lot 1212839121 and released on review of results of sterilization. All the results were within specification and the products were released. The production process, in process testing and packaging of products was run in accordance with process instructions (pi) for machine doyen 4. A visual inspection was performed in accordance to testing methods (tm) and completed at the beginning of the order and every hour until the order was completed. A nonconformance was raised during the manufacturing process however, it was for a different issue. This is the only complaint for the affected lot within complaint handling system. Four (4) photographs have been received for this complaint issue and have been evaluated in accordance to work instructions. The photographs confirm the batch number, the product and the complaint issue. The contamination appears to be excess tow from the textile process mixed in with the fabric. However, no physical sample is being returned therefore it cannot be confirmed what the foreign matter is. A non-conformance was opened for this issue. No investigation was required as the root cause was already known. A new cleaning program is being implemented onto the machine to stop excess tow from getting into the fabric. The non-conformance is closed. This issue will be monitored through the post market product monitoring review process. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[186555104]
To date no additional patient or event details have been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2019-00117 |
| MDR Report Key | 9496350 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-12-19 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2019-12-19 |
| 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 | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | CONVATEC LTD |
| Manufacturer Street | FIRST AVENUE DEESIDE INDUSTRIAL PARK |
| Manufacturer City | DEESIDE, FLINTSHIRE CH5 2NU |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CH5 2NU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUACEL/AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESSING |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FRO |
| Date Received | 2019-12-19 |
| Model Number | 403710 |
| Lot Number | 8D0227 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LTD |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH5 2NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-19 |