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 COMBOCARE E-STIM AND ULTRASOUND COMBO DQ7844 manufactured by Shenzhen Dongdixin Technology Co., Ltd..
[89566212]
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 use didn't use the electrode which provided by manufacturer. The most likely reason that caused burns is that impedance of the electrode used by user is not uniform. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89566213]
A doctor called to say she has a patient claiming he received a third degree burn while receiving treatment from our combocare. The doctor said she was using if-4p on her (b)(6)-year-old patient. This patient has received this treatment 8 times previously with her. The electrodes had been used 8 times before, so this was the 9th use of this set of electrodes. The patient had no hair in the area where the electrodes were placed, which was two on his upper thoracic and two on his mid to lower back. The doctor states the electrodes were 6" to 8" apart from one another. The doctor was one minute into a 15 minute therapy when the patient stated he felt pain (he called it a jolt). She turned the intensity down to a level where he could barely feel the treatment, and they completed the balance of the therapy. She removed the electrodes and noticed there was no red marks or any type of irritation on the skin. However, 2 hours later, the patient returned with what he said was a burn. A that time, she noticed a small black mark in the center of a ring of blisters. She recommended the patient see his primary care physician or visit an urgicare. His primary care doctor was not available, so the patient went to the urgicare. There, they told him it was a third degree burn (according to the patient) with possibly a (b)(6) infection. The doctor requested the medical records from the urgicare, but to date, he has not received them. According to the patient, he was told he would have permanent scarring. The returned device tested within spec range, and the customer's complaint of improper current output could not be duplicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-2017-00007 |
| MDR Report Key | 6957385 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-18 |
| Date of Report | 2016-07-19 |
| Date of Event | 2016-06-24 |
| Date Mfgr Received | 2016-07-20 |
| Device Manufacturer Date | 2015-08-13 |
| 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 | 0 |
| 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 | COMBOCARE E-STIM AND ULTRASOUND COMBO |
| Generic Name | ELECTROTHERAPY DEVICE |
| Product Code | GZJ |
| Date Received | 2017-10-18 |
| Model Number | DQ7844 |
| Operator | OTHER HEALTH CARE 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,518108 SHENZHEN, GUANGDONG 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-18 |