MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-04-01 for #N/A 420824 manufactured by Convatec Ltd.
[141081635]
(b)(6). Based on the available information, this event is deemed to be a reportable malfunction. A batch record review indicates no discrepancies. Machine logs have been checked and no discrepancies were found. Preventive maintenance (pm) logs were checked and all pms were completed with no issues found. Lot # 8h03070 was sterilized under lot 1216022711 and released on review of results of sterilization. All of the results were within specification and products were released in compliance with standard operating procedures. The production process, in process testing and packaging of products was run in accordance with process instructions for machine doyen 3. Visual inspection was performed in accordance with test methods and was completed at the beginning of the order and every hour following until the order was complete. No nonconformity was raised during the manufacturing process of lot 8h03070. This is the only complaint for the affected lot registered within tw8. 7. Two (2) photographs have been received for this issue and have been evaluated in accordance with work instructions. The photographs confirm the complaint issue, the lot number and that this is the product expected. The photographs show dark specks on the dressings however as the dressings are no being returned it cannot be confirmed what the foreign matter is. Operators will be made aware of the complaint issue. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141081636]
It was reported "one of the corner is covered in dots of mold. The pocket was sealed properly too. " photos depicting the reported complaint issue were provided by the complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2019-00044 |
| MDR Report Key | 8470208 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-04-01 |
| Date Mfgr Received | 2019-03-08 |
| Date Added to Maude | 2019-04-01 |
| 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 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 | #N/A |
| Generic Name | NOT APPLICABLE |
| Product Code | NAC |
| Date Received | 2019-04-01 |
| Model Number | 420824 |
| Lot Number | 8H03070 |
| Device Availability | N |
| 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 | 2019-04-01 |