MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-23 for INTENSITY MT2400(DQ7000) manufactured by Shenzhen Dongdixin Technology Co., Ltd..
[114800430]
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 found that the patient used a lower brand and non-clinical grade electrodes from the complaint description, so we assumed that patients was burned due to uneven distribution of the non-standard, non-clinical grade common electrode. We have been following up this event and ask distributor for more information to analysis.
Patient Sequence No: 1, Text Type: N, H10
[114800431]
The customer was using the device and a patient had it at 37 while using fabric top bluehand electrodes 2" round. They were placed within 4-6 inches apart from each other. The electrodes were new at the time of the accident. The burns appeared immediately after treatment was completed. The burn has left a permanent scar. They didn't seek any medical attention and no allergies were reported. The first burn is on upper right side of neck (back of neck). It is approximately 1/2" oval shape, flaky skin on edges, pink ring, then a white center with a brown dot on upper portion. The second burn is approximately 3" below the first burn and is on upper right side of spine on upper shoulder area and is approximately a 1/2" circle shape, flaky skin on edges, pink ring, with a yellow/brown center. The third burn is 1/2" below the second burn and is approximately a 1" circle shape, flaky skin on edges, pink ring, with a dark brown center. The treatment was if-4p acute setting, electrodes were in the x pattern, the treatment time was 5 minutes. The user manual states "the use of accessories, transducers and cables than those specified, with the exception of transducers and cables sold by the manufacturer as replacement parts for internal components, may result in increased emissions or decreased immunity of the device. On page 10 of the manual under general precautions it states the following: use this device only with the leads, electrodes, and accessories recommended by the manufacturer. On page 32 of the manual under caution it states the following: connection of accessories other than the ones specified by the manufacturer can adversely affect the safety of the patient and correct functioning of the equipment, and is therefore not permitted. On page 46 under caution it states the following: always use the electrodes with ce mark, or are legally marketed in the us under 510(k) procedure. The 510(k) for the blue hand electrodes states they are otc electrodes, not clinical grade electrodes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-2018-00008 |
| MDR Report Key | 7713118 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-23 |
| Date of Report | 2018-06-25 |
| Date Mfgr Received | 2018-06-26 |
| Device Manufacturer Date | 2016-07-28 |
| Date Added to Maude | 2018-07-23 |
| 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 | MRS |
| 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 | EX4 PROFESSIONAL |
| Product Code | GZJ |
| Date Received | 2018-07-23 |
| Model Number | MT2400(DQ7000) |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-07-23 |