MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for COMPASS HEALTH BRANDS DQ8450 manufactured by Shenzhen Dongdixin Technology Co, Ltd.
[107198855]
The end-user received electrical muscle stimulation (ems) treatment from a d. C. , l. Ac. The end-user alleges that as a result of this treatment, she suffered third degree burns on her neck and back, subsequent infection, a skin graft, scarring and disfigurement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00025 |
| MDR Report Key | 7482524 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-05-03 |
| Date of Event | 2017-09-01 |
| Date Facility Aware | 2018-04-13 |
| Report Date | 2018-05-03 |
| Date Reported to FDA | 2018-05-03 |
| Date Reported to Mfgr | 2018-05-03 |
| Date Added to Maude | 2018-05-03 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPASS HEALTH BRANDS |
| Generic Name | QUATTRO 2.5 |
| Product Code | GZJ |
| Date Received | 2018-05-03 |
| Model Number | DQ8450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD |
| Manufacturer Address | NO. 3 BUILDING XILIBAIMANG XUS ESTATE, NANSHAN, SHENZHEN SHENZHEN GUANGDONG, 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-05-03 |