MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. INTENSITY; TENS UNIT

Model Number DI4738

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Fibrillation (1729)

Event Date 01/11/2019

Event Type  Injury  

Event Description

An insurance company called (b)(4), (b)(6) 2019.The insurance company defending a case regarding a intensity if combo device, di4738 - they requested assistance proving this device cannot cause atrial fibrillation in a patient.They are attempting to prove the physical therapist using this device was negligent in using it.The insurance company called to see if anyone in our company can dispute causation & is looking for someone to testify and defend that the device cannot cause atrial fibrillation in a patient.No alleged product problem is being reported at this time (as mentioned above, the insurance company is attempting to prove the physical therapist using this device was negligent in using it).No further details regarding the user's condition before or regarding this alleged event available at this time.

• Brand Name: INTENSITY
• Type of Device: TENS UNIT
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.; no. 3 building xilibaimang xus; industrial estate nanshan; shenzhen guangdong, 51810 8; CH 518108
• MDR Report Key: 8308514
• MDR Text Key: 135150018
• Report Number: 3012316249-2019-00004
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DI4738
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Distributor Facility Aware Date: 01/11/2019
• Date Report to Manufacturer: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other