MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-04-28 for INTENSITY DQ7000(MT2400) manufactured by Shenzhen Dongdixin Technology Co., Ltd.
[106829721]
We checked the dhf and dmr for mt2400, no problems were found. And the device history record was examined for the subject device. There were no problems observed during the manufacturing or testing noted in the dhr. We have been following up this event and ask distributor for more information to analysis.
Patient Sequence No: 1, Text Type: N, H10
[106829722]
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. Therapist states she always uses the preset for acute pain/4 electrodes. First our product manager said these were not clinical grade electrodes because we sell the electrodes, the brand electrodes they claim to be using. Later she recanted and said they also purchase electrodes from other manufacturers and now she isn't sure. A day after the initial report the end-user admits they do not know which device(s) burned patients as they did not keep track. The serial numbers for these devices are (b)(4). Devices (b)(4) were returned and inspected on (b)(6) 2018. The warranty seals were broken on both devices, no cosmetic defects were found, and both devices tested for product performance and determined to fall within the manufacturer's specifications as defined in the product user manual.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-2018-00007 |
| MDR Report Key | 7471171 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-04-28 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-03-29 |
| Date Added to Maude | 2018-04-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS SIPING YUAN |
| Manufacturer Street | BLOCK A, 5TH FLOOR, FUHUA TECH NO. 9116 BEIHUAN ROAD |
| Manufacturer City | SHENZHEN, GUANGDONG 518057 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518057 |
| Manufacturer G1 | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD |
| Manufacturer Street | NO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,NANSHAN |
| 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 |
| Generic Name | ELECTROTHERAPY DEVICE |
| Product Code | GZJ |
| Date Received | 2018-04-28 |
| Model Number | DQ7000(MT2400) |
| 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,NANSHAN SHENZHEN, GUANGDONG 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-28 |