MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-25 for INTENSITY DQ7000 manufactured by Shenzhen Dongdixin Technology Co, Ltd.
[112284108]
Patient Sequence No: 1, Text Type: N, H10
[112284109]
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 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 | 3012316249-2018-00037 |
| MDR Report Key | 7635574 |
| Date Received | 2018-06-25 |
| Date of Report | 2018-07-06 |
| Date Facility Aware | 2018-06-06 |
| Report Date | 2018-07-06 |
| Date Reported to FDA | 2018-07-06 |
| Date Reported to Mfgr | 2018-07-06 |
| Date Added to Maude | 2018-06-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTENSITY |
| Generic Name | EX4 PROFESSIONAL |
| Product Code | GZJ |
| Date Received | 2018-06-25 |
| Model Number | DQ7000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD |
| Manufacturer Address | NO. 3 BUILDING XILIBAIMANG XUS ESTATE, NANSHAN, SHENZHEN SHENZHEN GUANGDONG, 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-25 |