MAUDE Adverse Event Report: WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD METRON SELF ADHESIVE ELECTRODES; ELECTRODE, CUTANEOUS

Model Number 32028582

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

Patient Problem Burn(s) (1757)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

Nmt purchases the device from (b)(4).The receipt of the original complaint was on (b)(6) 2021 stated "there was no serious injury or death.This was a minor injury that needed minor treatment.They put a bandage over the wound.The patient did not see a dr only a physical therapist.This physical therapist was a traveling therapist who has already left the facility.The customer noted she can reach out if more information in needed from that physical trainer.The type of treatment that was being used was interferential.(b)(6) stated the ifu for product is assumed to have been used.The intensity was at 61 with the length of time of 15 minutes.Therapist can treat under scope of practice not by order.The patient did discontinued use of this product.The equipment was taken out of service as well.Patient mentioned injury a day later, was not initially apparent.The wound was in the general area of where the equipment was used." this information was forwarded to (b)(4) on (b)(6) 2021 for investigation.(b)(4) requested additional information, which was provided by nt including the unit the electrode was used with: "the unit was a dynatronic ultrasound stimulation unit (model#d708 / serial#(b)(4)).Manufacture date was 10/2003.Let me know if there is any other information that is needed." nmt was provided the fda medwatch report on 1/21/2022 with more details of the " burn" and this report was provided to (b)(4) on (b)(6) 2022.This is when nmt determined that as the importer, the event was reportable.To date (b)(4) has offered the following, "we think it could be low temperature burn, it happened because there is no heat dissipation during the treatment.This is only our conjecture." no samples have been returned for evaluation or photos.

Event Description

On (b)(6) 2021, the first report of an issue with tns metron electrode 2" square was reported, however very little information was given.On (b)(6) 2021, it was reported to (b)(6) customer service by (b)(6) that "there was no serious injury or death.This was a minor injury that needed minor treatment.They put a bandage over the wound.The patient did not see a dr only a physical therapist.This physical therapist was a traveling therapist who has already left the facility.The customer noted she can reach out if more information in needed from that physical trainer.The type of treatment that was being used was interferential.(b)(6) stated the ifu for product is assumed to have been used.The intensity was at 61 with the length of time of 15 minutes.Therapist can treat under scope of practice not by order.The patient did discontinued use of this product.The equipment was taken out of service as well.Patient mentioned injury a day later, was not initially apparent.The wound was in the general area of where the equipment was used." with this original information it was determined that the event was not reportable at this time due no serious injury or death.However on (b)(6) 2022, nmt was made aware of that an fda medwatch report was initiated by the customer which stated the patient had a " single, small, circular burn-like sore" from use of the device.With this information, nmt deemed the event to be reportable.

• Brand Name: METRON SELF ADHESIVE ELECTRODES
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD; no. 35 baiqiao rd., ehu town; xishan district,, wuxi,; jiangsu, china 21411 6; CH 214116
• MDR Report Key: 13399329
• MDR Text Key: 289347986
• Report Number: 1317188-2022-00002
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 10885914070755
• UDI-Public: 10885914070755
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2021,01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 32028582
• Device Catalogue Number: TNS METRON ELECTRODE 2" SQUARE
• Device Lot Number: 172026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2021
• Distributor Facility Aware Date: 01/21/2022
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other