MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-04-20 for COMPASS HEALTH BRANDS DI1010(INTENSITY 10) manufactured by Shenzhen Dongdixin Technology Co., Ltd..
[106009091]
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 was returned for analysis and testing, the product performance and operation was determined to fall within the manufacturer's specifications.
Patient Sequence No: 1, Text Type: N, H10
[106009092]
This end-user states as he was turning the intensity down on this device, one channel at a time, and almost at zero on each channel, the device shot out the highest intensity feeling and pushed his shoulder back on the couch. It took him 10 seconds or so to turn the device off. He was shaking and sweating. Since then the muscles in his shoulder and neck are very sensitive to the touch. He is having pain and states physiotherapy is not helping. X-rays were normal. Results from the ultrasound: a small amount of fluid is seen within the biceps tendon sheath suggesting tendinitis. The tendon is intact. There is some fluid in the bursa adjacent to the bicep tendon and subscapularis. The subscapularis, infraspinatus and ac joint appear normal. There is a hypoechoic gap in the supraspinatus measuring 13 x 5 mm consistent with a full thickness tear. He states his doctor recommends to have a cortisone shot to relieve the inflammation and the pain. He states his doctor said it probably aggravated his injury. He had a cortisone shot in the bicep tendon for pain. The device involved with this event was returned to compass health brands on 01/24/2018 and the customer's complaint was unable to be duplicated. The device was tested for product performance and determined to fall within the manufacturer's specifications as defined in the product's user manual.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-2018-00003 |
| MDR Report Key | 7445930 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-04-20 |
| Date of Report | 2018-03-16 |
| Date of Event | 2017-12-27 |
| Date Mfgr Received | 2018-03-19 |
| Device Manufacturer Date | 2015-09-30 |
| Date Added to Maude | 2018-04-20 |
| 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 | COMPASS HEALTH BRANDS |
| Generic Name | INTENSITY 10 DIGITAL TENS |
| Product Code | GZJ |
| Date Received | 2018-04-20 |
| Returned To Mfg | 2018-03-23 |
| Model Number | DI1010(INTENSITY 10) |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-04-20 |