MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-28 for INTENSITY manufactured by Shenzhen Dongdixin Technology Co., Ltd.
[103777020]
Clinic called today stating they purchased 3 intensity ex4's from the above distributor. They state they have had multiple patients burned on all three of their devices. She is using latex free electrodes from total medical resources. She used a lower brand from them but then changed to their platinum version. Burns occurred with both. She is using the electrodes in a criss-cross pattern. (they use the electrodes between 6" on the neck and/or low back. In each case only one electrode burned the patient. ) our product manager said these electrodes are not "clinical grade" electrodes. When questioned about the intensity levels they were using i was told they do go by patient feel. None of their patients felt their intensity was too high or even realized they had a burn until an hour or two later. The wide variation of intensity they have used goes from 8-35, rarely do they go above 40. A day after the initial report she admits they do not know which device(s) burned patients as they did not keep track. The customer states the patient received a 3rd degree burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012316249-2018-00014 |
| MDR Report Key | 7379632 |
| Date Received | 2018-03-28 |
| Date of Report | 2018-04-05 |
| Date of Event | 2018-03-07 |
| Date Facility Aware | 2018-03-07 |
| Report Date | 2018-04-05 |
| Date Reported to FDA | 2018-04-05 |
| Date Reported to Mfgr | 2018-04-05 |
| Date Added to Maude | 2018-03-28 |
| 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 | INTENSITY |
| Generic Name | ELECTROTHERAPY DEVICE |
| Product Code | GZJ |
| Date Received | 2018-03-28 |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD |
| Manufacturer Address | XILIBAIMANG XUSHENG INDUSTRIAL ESTATE, NANSHAN, SHENZHEN SHENZHEN GUANGDONG, CHINA CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-28 |