MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-06-13 for KERRAMAX CARE manufactured by Crawford Healthcare Ltd.
| Report Number | 3004051837-2019-00007 |
| MDR Report Key | 8694887 |
| Report Source | CONSUMER |
| Date Received | 2019-06-13 |
| Date of Report | 2019-06-13 |
| Date of Event | 2019-05-17 |
| Date Mfgr Received | 2019-05-17 |
| Date Added to Maude | 2019-06-13 |
| 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 | MR ANDREW JACKSON |
| Manufacturer Street | KING EDWARD COURT KING EDWARD ROAD |
| Manufacturer City | KNUTSFORD, WA160BE |
| Manufacturer Country | UK |
| Manufacturer Postal | WA16 0BE |
| Manufacturer G1 | CRAWFORD HEALTHCARE LTD |
| Manufacturer Street | KING EDWARD COURT KING EDWARD ROAD |
| Manufacturer City | KNUTSFORD, WA160BE |
| Manufacturer Country | UK |
| Manufacturer Postal Code | WA16 0BE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KERRAMAX CARE |
| Generic Name | KERRAMAX CARE |
| Product Code | NAC |
| Date Received | 2019-06-13 |
| 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 | 2019-06-13 |