MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-17 for INTENSITY SELECT COMBO - TENS/IF/MIC/EMS DI8195 manufactured by Shenzhen Dongdixin Technology Co., Ltd..
[89457417]
The device history record was examined for the subject device. There were no problems observed during the manufacturing or testing noted in the dhr. The device labeling was reviewed and found to be suitable and adequate for the device to perform its intended use. The device can not use on head. The most likely reason that caused burns is that user didn't follow the instructions in the user manual.
Patient Sequence No: 1, Text Type: N, H10
[89457418]
When using the microcurrent settings for transcranial therapy of a tens unit, the patient found the unit uncomfortable - the unit had burned his ears when set at. 35ma. The doctor thought this could not be possible because, based on his knowledge, the threshold for a human feeling current is. 5ma to 1ma. (update received (b)(6) 2016) the patient received second degree burns - the blisters itched and then scabbed over. They applied antibiotic ointment from that point until the burns were healed. There are still some small residual bumps on the back of his earlobes - these are not itchy nor scabbing. The unit was returned to (b)(4) on 3/7/2016 and tested on channels 1 and 2 with both the returned end-user's lead wires and in-house testing sample lead wires - the device appeared to be within spec range overall. The customer's complaint was unable to be duplicated upon a review of the returned device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-2017-00002 |
| MDR Report Key | 6953917 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-17 |
| Date of Report | 2016-03-14 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2016-03-15 |
| Device Manufacturer Date | 2015-11-10 |
| Date Added to Maude | 2017-10-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR KANG JIANPING |
| Manufacturer Street | BLOCK A, 5TH FLOOR, FUHUA TECH NO. 9116 BEIHUAN ROAD |
| Manufacturer City | SHENZHEN, GUANGDONG 518108 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518108 |
| Manufacturer G1 | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
| Manufacturer Street | NO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,518108 |
| Manufacturer City | SHENZHEN, GUANGDONG 518108 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 518108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTENSITY SELECT COMBO - TENS/IF/MIC/EMS |
| Generic Name | TTENS UNIT |
| Product Code | GZJ |
| Date Received | 2017-10-17 |
| Model Number | DI8195 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
| Manufacturer Address | NO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,518108 SHENZHEN, GUANGDONG 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-17 |