MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-16 for ACHIEVMENT REHAB M2 manufactured by Achievment Rehab.
[1072014]
Burn to left leg 4 cm x 2 cm noticed after hot pack treatment applied by therapy. Hydrocollator temp 169 degrees. Resident denied pain during therapy. Therapy used appropriate procedures with this method - 4 layer w/heat pack. Equipment was tested within allowable range 169 degrees.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010358 |
| MDR Report Key | 1345978 |
| Date Received | 2009-03-16 |
| Date of Report | 2009-03-16 |
| Date of Event | 2009-02-12 |
| Date Added to Maude | 2009-05-14 |
| 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 |
| 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 | ACHIEVMENT REHAB |
| Generic Name | WATER HEATER FOR HOT PACK THERAPY |
| Product Code | IRQ |
| Date Received | 2009-03-16 |
| Model Number | M2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACHIEVMENT REHAB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-16 |