COMPASS HEALTH BRANDS DI1010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-16 for COMPASS HEALTH BRANDS DI1010 manufactured by Shenzhen Dongdixin Technology Co., Ltd.

Event Text Entries

[102711679] 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 (b)(6) 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

MAUDE Entry Details

• Report Number: 3012316249-2018-00011
• MDR Report Key: 7346058
• Date Received: 2018-03-16
• Date of Report: 2018-03-16
• Date of Event: 2017-12-22
• Date Facility Aware: 2018-02-23
• Report Date: 2018-03-16
• Date Reported to FDA: 2018-03-16
• Date Reported to Mfgr: 2018-03-16
• Date Added to Maude: 2018-03-16
• 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
• Reporter Occupation: PATIENT
• 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

Device Details

• Brand Name: COMPASS HEALTH BRANDS
• Generic Name: INTENSITY 10 DIGITAL TENS
• Product Code: GZJ
• Date Received: 2018-03-16
• Model Number: DI1010
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: 30 MO
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD
• Manufacturer Address: XILIBAIMANG XUSHENG INDUSTRIAL BUILDING 518108 NANSHAN SHENZHEN, CH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2018-03-16