MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-05-13 for MOIST HEATING DEVICE manufactured by Djo, Llc.
[15770396]
Lawsuit received stating that "while being treated with a moist heating device, the patient suffered a full thickness burn to her leg, necrosis of the skin and tendon, and permanent injury and disfigurement to her knee. " product not returned for evaluation or review, unable to confirm this is a djo, llc product based on lawsuit alone. No additional information received from patient, clinician and/or lawyer regarding additional details of incident. Lawsuit claims patient is unable to perform many of the necessary duties of a spouse, and will be unable to perform such duties in the future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2013-00008 |
| MDR Report Key | 3115573 |
| Report Source | 00 |
| Date Received | 2013-05-13 |
| Date of Report | 2013-05-13 |
| Date of Event | 2011-08-26 |
| Date Added to Maude | 2013-05-17 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION ST. |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | MOIST HEATING DEVICE |
| Product Code | IMA |
| Date Received | 2013-05-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION ST. VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2013-05-13 |