MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-26 for QUATTRO 2.5 DQ8450 manufactured by Shenzhen Dongdixin Technology Co, Ltd..
[90392456]
The clinic states the patient was burned while being treated on this device. They were using two electrodes on each knee, each 4-5" away from each other. The patient was feeling discomfort during treatment, and stated the therapy was feeling hot. When they checked, she was bleeding under the electrode, and had received a burn. The burn is reported as having lasted one week as red and blistered after having immediately showing up on the patient's skin. The device was set to tens waveform, and the assistant believes they were using program 1. The lead wires had never been replaced on this device. The device involved with this event was returned to (b)(4) on 10/10/2017 and evaluated on 10/11/2017 - the customer's complaint could not be duplicated from a review of the returned device. The returned device was tested for product performance, and determined to fall within the manufacturer's specifications, 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 | 3012316249-2017-00126 |
| MDR Report Key | 6982112 |
| Date Received | 2017-10-26 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-09-11 |
| Date Facility Aware | 2017-10-03 |
| Report Date | 2017-10-26 |
| Date Reported to FDA | 2017-10-26 |
| Date Reported to Mfgr | 2017-10-26 |
| Date Added to Maude | 2017-10-26 |
| 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 | 0 |
| Brand Name | QUATTRO 2.5 |
| Generic Name | CLINICAL DEVICE |
| Product Code | GZJ |
| Date Received | 2017-10-26 |
| Model Number | DQ8450 |
| Catalog Number | DQ8450 |
| 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 | 2017-10-26 |