MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-27 for COMBOCARE DQ7844 manufactured by Shenzhen Dongdixin Technology Co, Ltd..
[90510792]
The doctor states that she had a patient burned on this device. The patient felt a burning sensation - they removed the electrodes, and the skin underneath was red with a white spot in the middle that was turning into a blister. She was using rubber electrodes with a good amount of gel, however, a burn only appeared under one electrode. The patient did feel a shock during therapy, and left the doctor with a 2cm (. 787") blister. The patient is reported as having felt a little discomfort during treatment, but thought it was normal - when the electrodes were removed from her skin, the skin had turned white & was peeling off on her buttox (electrodes were 4" apart). The burns are reported as having lasted to date (upon notification of event to (b)(4)). The patient is also reported as having received medical attention for the injury. The device involved with this event was returned to (b)(4) and evaluated on 10/25/2017 - the customer's complaint could not be duplicated from a review of the returned device. The device was tested for product performance, and determined to fall within the manufacturer's specifications for comb. & stim, as defined in the product's user manual. Again, the customer's complaint could not be duplicated from a review of the returned device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2017-00128 |
| MDR Report Key | 6985651 |
| Date Received | 2017-10-27 |
| Date of Report | 2017-10-27 |
| Date of Event | 2017-10-04 |
| Date Facility Aware | 2017-10-04 |
| Report Date | 2017-10-27 |
| Date Reported to FDA | 2017-10-27 |
| Date Reported to Mfgr | 2017-10-27 |
| Date Added to Maude | 2017-10-27 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COMBOCARE |
| Generic Name | CLINICAL DEVICE |
| Product Code | GZJ |
| Date Received | 2017-10-27 |
| Model Number | DQ7844 |
| Catalog Number | DQ7844 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 INDUSTRIAL ESTATE NANSHAN SHENZHEN GUANGDONG, 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-10-27 |