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 2018-03-09 for DONJOY 82-0014-4 manufactured by Djo, Llc.
[102016276]
Complaint received that alleges "skin burn". Photographs indicate open sores and blisters.
Patient Sequence No: 1, Text Type: D, B5
[106745891]
Returned product inspected and complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007615436-2018-00001 |
| MDR Report Key | 7327947 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-03-20 |
| Date Added to Maude | 2018-03-09 |
| 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 | WILLIAM FISHER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJO TUNISIE |
| Manufacturer Street | ZONE INDUSTRIELLE POUDRIERE 1, AOUT, |
| Manufacturer City | SFAX, SFAX 3002 |
| Manufacturer Country | TS |
| Manufacturer Postal Code | 3002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DONJOY |
| Generic Name | SUPPORT EVEREST ICE - L |
| Product Code | IME |
| Date Received | 2018-03-09 |
| Model Number | 82-0014-4 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-09 |