MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-03-06 for CAREMAX CAREMAX DPRL A5144 manufactured by Weigi International.
[3387311]
Rn's wife contacted customer service on (b)(6) 2013 to report that she wanted to return the care max dprl and that her husband had rec'd a burn from the product. At that time she indicated that she would probably take him to see a doctor. A f/u conversation was held with rn and his wife on (b)(4) 2013. (b)(6) reported that rn had visited a doctor and was treated for a 3rd degree burn approx the size of a half dollar on his shoulder. Rn is an amputee and was unsuccessful at putting the device on his stump properly because he only has one hand. He did not put the protective cloth under the unit in order to protect his skin. Rn has no feeling in his stump and was unable to feel the unit burning his skin. He stated that he wasn't sure how long he used the unit, but that it was less than 25 mins. The doctor treated the wound with antibiotics, cream and uv treatment light. (b)(6) feels the wound is healing nicely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528424-2013-00001 |
| MDR Report Key | 2999775 |
| Report Source | 99 |
| Date Received | 2013-03-06 |
| Date of Report | 2013-03-06 |
| Date of Event | 2013-02-18 |
| Date Facility Aware | 2013-02-20 |
| Report Date | 2013-03-06 |
| Date Reported to FDA | 2013-03-06 |
| Date Added to Maude | 2013-03-13 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREMAX |
| Generic Name | CAREMAX DPRL, HEATED CARE BRACE |
| Product Code | ITO |
| Date Received | 2013-03-06 |
| Model Number | CAREMAX DPRL |
| Catalog Number | A5144 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WEIGI INTERNATIONAL |
| Manufacturer Address | KOWLOON HK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-06 |