MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-16 for KERRALITE COOL CWL1005 manufactured by Crawford Healthcare Ltd.
| Report Number | 3004051837-2019-00008 |
| MDR Report Key | 8903800 |
| Date Received | 2019-08-16 |
| Date of Report | 2019-08-05 |
| Date of Event | 2019-07-16 |
| Date Mfgr Received | 2019-07-17 |
| Date Added to Maude | 2019-08-16 |
| 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 | MISS ELIZABETH WOODS |
| Manufacturer Street | KING EDWARD COURT KING EDWARD ROAD |
| Manufacturer City | KNUTSFORD, WA 16 0BE |
| Manufacturer Country | UK |
| Manufacturer G1 | CRAWFORD HEALTHCARE LTD |
| Manufacturer Street | KING EDWARD COURT KING EDWARD ROAD |
| Manufacturer City | KNUTSFORD, |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KERRALITE COOL |
| Generic Name | KERRALITE COOL, PRODUCT CODE: NAE |
| Product Code | NAE |
| Date Received | 2019-08-16 |
| Model Number | CWL1005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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, UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-16 |