MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. QUATTRO 2.5; TENS UNIT

Model Number DQ8450

Device Problems Electrical /Electronic Property Problem (1198); Device Issue (2379); Output Problem (3005)

Patient Problem Burn(s) (1757)

Event Date 09/14/2016

Event Type  Injury  

Event Description

The distributor states that their patient was burned during use of the tens unit.According to the compass health brands customer service representative, this call was very confusing - there was little information to provide, and the person the representative had spoken to's story changed a couple of times; he seemed unsure of himself.The representative did not believe that the person (he) knew the answers to the questions the rep was asking, and felt he was guessing in response to some questions asked.The person the representative had spoken to while obtaining some answers to some questions states he was a physical therapist - however, he was not the pt in the room when the patient was burned - he stated that this therapist is no longer with the clinic.The representative asked what waveform had been used on the end-user, but the person asking the questions is reported as not having understood the word waveform - the representative reviewed all the waveforms, and chose ems - he later stated that they use the waveform that comes up when they power the device on, he thought if-4p.He was unclear of the end-user's age, and guessed (b)(6).The burn happened at the therapist's office while the pt was in the room with the end-user.He stated immediately the end-user felt shocking, and when the electrodes were removed, a burn mark was evident.He states the electrodes were placed 1" to 6" apart on the user's lower back.They were using 2x2 electrodes.The end-user did seek medical treatment, but the pt does not have any records from that treatment.

• Brand Name: QUATTRO 2.5
• Type of Device: TENS UNIT
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.; no. 3 building xilibaimang xus; industrial estate nanshan; shenzhen guangdong, china 51810 8; CH 518108
• MDR Report Key: 6042756
• MDR Text Key: 57918167
• Report Number: 3005182235-2016-00036
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physical Therapist
• Device Model Number: DQ8450
• Device Catalogue Number: DQ8450
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2016
• Distributor Facility Aware Date: 09/28/2016
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/19/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR