MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-18 for QUATTRO 2.5 DQ8450 manufactured by Shenzhen Dongdixin Technology Co., Ltd..
[89566744]
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
[89566745]
The distributor states that their patient was burned during use of the tens unit. According to the (b)(4) customer service representative, this call was very confusing - there was little information to provide, and the person the representative had spoken to's story changed a couple of times; he seemed unsure of himself. The representative did not believe that the person (he) knew the answers to the questions the rep was asking, and felt he was guessing in response to some questions asked. The person the representative had spoken to while obtaining some answers to some questions states he was a physical therapist - however, he was not the pt in the room when the patient was burned - he stated that this therapist is no longer with the clinic. The representative asked what waveform had been used on the end-user, but the person asking the questions is reported as not having understood the word waveform - the representative reviewed all the waveforms, and chose ems - he later stated that they use the waveform that comes up when they power the device on, he thought if-4p. He was unclear of the end-user's age, and guessed (b)(6). The burn happened at the therapist's office while the pt was in the room with the end-user. He stated immediately the end-user felt shocking, and when the electrodes were removed, a burn mark was evident. He states the electrodes were placed 1" to 6" apart on the user's lower back. They were using 2x2 electrodes. The end-user did seek medical treatment, but the pt does not have any records from that treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-2017-00008 |
| MDR Report Key | 6957381 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-18 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-09-14 |
| Date Mfgr Received | 2016-10-19 |
| Device Manufacturer Date | 2016-01-11 |
| Date Added to Maude | 2017-10-18 |
| 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 | 2017-10-18 |
| Model Number | DQ8450 |
| Operator | PHYSICAL THERAPIST |
| 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 | 2017-10-18 |