MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,08 report with the FDA on 2015-06-04 for CHATTANOOGA FLU115D manufactured by Djo, Llc.
[16634793]
Complaint received from fda medwatch program that alleges "during treatment, the patient complained of temperature being too hot and temp was turned down and patient left to continue treatment. When patient was taken out of the device, it was noticed that his right 5th digit (from the pip joint to the finger tip) was burned to the point that the skin was actually off finger. Burn "get" was placed on finger with loose gauze, patient was escorted to ed for further evaluation (no ed details available to djo)". Questionnaire was not received from clinician and/or patient. Device was not returned to mfr for evaluation. Mw ref#: 5040428.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2015-00013 |
| MDR Report Key | 4824897 |
| Report Source | 00,08 |
| Date Received | 2015-06-04 |
| Date of Report | 2015-06-04 |
| Date of Event | 2015-01-09 |
| Date Added to Maude | 2015-06-09 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | FLUIDOTHERAPY |
| Product Code | LSB |
| Date Received | 2015-06-04 |
| Model Number | FLU115D |
| 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. Other | 2015-06-04 |