MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-23 for FLUIDOTHERAPY FLU115D manufactured by Chattanooga Djo, Llc.
[5180698]
Patient was seen on (b)(6) 2015 for occupational therapy treatment session. Upon arrival, patient was placed in the fluidotherapy machine for 15 minutes at 115 degrees. As the patient was receiving treatment the therapist was approx 10 feet away at another workstation providing treatment to another patient. After approx 10 minutes into the treatment session he did complain that it was getting too hot and at that time the temperature was lowered to 88 degrees. He was taken out of the machine after 15 minutes and noticed that his right 5th digit (from the pip joint to the fingertip) was burned to the point that the skin was actually off the finger, burn "get" was placed on the finger with a loose fitting gauze as well. Patient was escorted to the ed for further evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040428 |
| MDR Report Key | 4465866 |
| Date Received | 2015-01-23 |
| Date of Report | 2015-01-16 |
| Date of Event | 2015-01-09 |
| Date Added to Maude | 2015-01-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUIDOTHERAPY |
| Generic Name | FLUIDOTHERAPY |
| Product Code | LSB |
| Date Received | 2015-01-23 |
| Model Number | FLU115D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA DJO, LLC |
| Manufacturer Address | VISTA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-23 |