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 QUATTRO 2.5 DQ8450 manufactured by Shenzhen Dongdixin Technology Co., Ltd..
[89457865]
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 most likely reason that caused burns is that user didn't follow the instructions to clean the skin surface over which electrodes are placed.
Patient Sequence No: 1, Text Type: N, H10
[89457866]
A doctor called in to say he had a patient that had been burned while being treated with a quattro 2. 5 tens unit. The doctor was not with the device when he called in to report the injury. The doctor needed further explanation and clarification regarding proper use of and terminology involved with tens unit use. The doctor denies use of ice or heat with the treatment. A follow-up with the doctor on (b)(6) 2016 concluded that the user had received 3rd degree burns, and is currently receiving treatment from a dermatologist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-2017-00005 |
| MDR Report Key | 6953915 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-17 |
| Date of Report | 2016-05-23 |
| Date of Event | 2016-04-29 |
| Date Mfgr Received | 2016-05-23 |
| Device Manufacturer Date | 2016-06-03 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | QUATTRO 2.5 |
| Generic Name | TENS UNIT |
| Product Code | GZJ |
| Date Received | 2017-10-17 |
| Model Number | DQ8450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Congenital Not Applicablenomaly; 2. Other | 2017-10-17 |