MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-05-03 for KERRACEL CWL1035 manufactured by Crawford Healthcare Ltd.
[143945730]
The incident was last year on a very deep and very narrow cavity wound and had broken on removal so had to use forceps to remove the remainder of the dressing, the patient was being seen by the district nurses. Facility do not want to make a formal complaint about the dressing and feels the additional product training will be sufficient to ensure the product is used appropriately and to prevent this from occurring again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004051837-2019-00006 |
| MDR Report Key | 8577299 |
| Report Source | FOREIGN |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-04-04 |
| Date Facility Aware | 2019-04-04 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-05-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KERRACEL |
| Generic Name | CWL1035 |
| Product Code | NAC |
| Date Received | 2019-05-03 |
| Model Number | CWL1035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRAWFORD HEALTHCARE LTD |
| Manufacturer Address | KING EDWARD COURT KING EDWARD ROAD KNUTSFORD, WA160BE UK WA16 0BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-03 |