Omron Max Power Relief TENS Therapy Pain Relief PM500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00073796635008), received between Sep 13, 2023 and Nov 1, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Excessive Heating” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2024Excessive Heating; Excessive Heating

  THE CONSUMER STATED THE UNIT HAS GIVEN HER 2ND AND 3RD DEGREE BURNS ON LOWER BACK TO THE SIDE OF HER BUTT CRACK. SHE STATED SHE HAD TO GO TO THE ER/URGENT CARE ON (B)(6) AND WAS TOLD SHE HAD AN ELECTRICAL BURN. SHE STATED SHE ONLY USED THE UNIT FOR THE 15 MINUTES REQUIRED AND WOULD TURN IT BACK ON MORE THAN A COUPLE OF TIMES (8-10 TIMES) THROUGHOUT THE DAY. SHE DID NOT USE ANY CREAMS OR OTHER PRODUCTS WITH THE UNIT. SHE WAS LYING ON HER SIDE. SHE STATED SHE WAS GIVEN BURN CREAM, ANTIBIOTICS AND A TETANUS SHOT DUE TO INFECTION AND DRAINAGE. DURING A FOLLOW UP CALL, SHE STATED THAT HER TENS UNIT LEFT BURN MARKS ON HER LOWER BACK AND POSTERIOR AND THAT THEY ARE 2ND AND 3RD DEGREE BURNS. SHE STATED THAT THE BURNS ARE SHAPED LIKE PADS AND ARE THE SIZE OF A CASABA MELON. SHE STATED THAT SHE HAS BEEN OFF WORK SINCE (B)(6) 2024. SHE IS A HAIRDRESSER. SHE STATED THAT SHE IS STILL FEELING PAIN. SHE WENT TO URGENT CARE PER DIRECTION OF HER DOCTOR. SHE IS ON ANTIBIOTICS AND BURN CREAM AND THEY ALSO GAVE HER TETANUS SHOT. SHE NEEDED TO CHANGE BANDAGES 2-3 TIMES A DAY. SHE STATED THAT THE UNIT WAS SET AT 9, THOUGH SOMETIMES 8. SHE COULD FEEL IT AND THAT WAS THE MAXIMUM SHE COULD TOLERATE. SHE ST

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 20586000 ↗
• InjuryOct 30, 2024Excessive Heating; Excessive Heating

  THE CONSUMER STATED THE UNIT HAS GIVEN HER 2ND AND 3RD DEGREE BURNS ON LOWER BACK TO THE SIDE OF HER BUTT CRACK. SHE STATED SHE HAD TO GO TO THE ER/URGENT CARE ON OCTOBER 6TH AND WAS TOLD SHE HAD AN ELECTRICAL BURN. SHE STATED SHE ONLY USED THE UNIT FOR THE 15 MINUTES REQUIRED AND WOULD TURN IT BACK ON MORE THAN A COUPLE OF TIMES (8-10 TIMES) THROUGHOUT THE DAY. SHE DID NOT USE ANY CREAMS OR OTHER PRODUCTS WITH THE UNIT. SHE WAS LYING ON HER SIDE. SHE STATED SHE WAS GIVEN BURN CREAM, ANTIBIOTICS AND A TETANUS SHOT DUE TO INFECTION AND DRAINAGE. DURING A FOLLOW UP CALL, SHE STATED THAT HER TENS UNIT LEFT BURN MARKS ON HER LOWER BACK AND POSTERIOR AND THAT THEY ARE 2ND AND 3RD DEGREE BURNS. SHE STATED THAT THE BURNS ARE SHAPED LIKE PADS AND ARE THE SIZE OF A CASABA MELON. SHE STATED THAT SHE HAS BEEN OFF WORK SINCE (B)(6) 2024. SHE IS A HAIRDRESSER. SHE STATED THAT SHE IS STILL FEELING PAIN. SHE WENT TO URGENT CARE PER DIRECTION OF HER DOCTOR. SHE IS ON ANTIBIOTICS AND BURN CREAM AND THEY ALSO GAVE HER TETANUS SHOT. SHE NEEDED TO CHANGE BANDAGES 2-3 TIMES A DAY. SHE STATED THAT THE UNIT WAS SET AT 9, THOUGH SOMETIMES 8. SHE COULD FEEL IT AND THAT WAS THE MAXIMUM SHE COULD TOLERATE. S

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 20569820 ↗
• InjurySep 18, 2023Fire; Fire

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770325 ↗
• InjurySep 13, 2023Fire; Fire

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17738457 ↗