MAUDE Adverse Event Report: OMRON (DALIAN) CO., LTD. (PLANT 1) MAX POWER RELIEF TENS THERAPY

Model Number PM500

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2023

Event Type  Injury  

Manufacturer Narrative

A root cause has not been determined.It has not been confirmed if the device caused or contributed to the reported incident; however, due to the customer reporting the unit caught fire this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.A postage label has been sent for retrieval of the home unit for inspection.The consumer was offered a refund or replacement unit.They refused both.

Event Description

The caller stated that his girlfriend's unit caught on fire.The pad was on top of the battery.He did not know if the unit was turned on, but he stated no one had gotten hurt.The caller stated he and his girlfriend were cooking lunch when they heard the fire alarm go off.He went into the bedroom and the unit was on fire on a wood dresser.He had thrown the unit out the window and left it there.He stated there was smoke and flames and the only damage done was to the dresser.The fire department was not called and there were no other issues.He stated the tens unit was on top of the controller.When asked what the controller was, he stated it was the buttons on the tens unit.He stated he was going to try to use the unit since he had pains in his legs.He was not using the unit at the time.He was not sure where the unit was purchased since it was his girlfriend's unit.It was the first day the unit was pulled from the box.He was using the original batteries.He stated the unit was not usable since it was all burned up.

Event Description

The caller stated that his girlfriend's unit caught on fire.The pad was on top of the battery.He did not know if the unit was turned on, but he stated no one had gotten hurt.The caller stated he and his girlfriend were cooking lunch when they heard the fire alarm go off.He went into the bedroom and the unit was on fire on a wood dresser.He had thrown the unit out the window and left it there.He stated there was smoke and flames and the only damage done was to the dresser.The fire department was not called and there were no other issues.He stated the tens unit was on top of the controller.When asked what the controller was, he stated it was the buttons on the tens unit.He stated he was going to try to use the unit since he had pains in his legs.He was not using the unit at the time.He was not sure where the unit was purchased since it was his girlfriend's unit.It was the first day the unit was pulled from the box.He was using the original batteries.He stated the unit was not usable since it was all burned up.

Manufacturer Narrative

A root cause has not been determined.It has not been confirmed if the device caused or contributed to the reported incident; however, due to the customer reporting the unit caught fire this medwatch is being filed.The u.S importer is requesting the manufacturer of the device to further investigate this incident.A postage label has been sent for retrieval of the home unit for inspection.The consumer was offered a refund or replacement unit.They refused both.The device was not returned to the distributor/manufacturer for investigation.The investigation was closed on 12/12/2023.Here is the summary of the manufacturer device investigation: the manufacturer shipping inspection was reviewed and the inspection for the lot including this unit serial number passed.The risk analysis document was reviewed and similar risk has been analyzed.There was no similar event reported for the same model in the past.Unit was not returned by consumer.The device was not received for evaluation; therefore, a device analysis could not be completed.No further investigation required.

• Brand Name: MAX POWER RELIEF TENS THERAPY
• Type of Device: TENS
• Manufacturer (Section D): OMRON (DALIAN) CO., LTD. (PLANT 1); no. 3 songjiang rd., economic; technical development zone; dalian, china 11660 0; CH 116600
• MDR Report Key: 17738457
• MDR Text Key: 323310322
• Report Number: 1450057-2023-00006
• Device Sequence Number: 1
• Product Code: NUH
• UDI-Device Identifier: 00073796635008
• UDI-Public: (01)00073796635008
• 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
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PM500
• Device Catalogue Number: PM500
• Device Lot Number: 201910U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2023
• Distributor Facility Aware Date: 08/25/2023
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 09/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Male