Omron Pocket Pain Pro PM400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00073796634001), received between Aug 29, 2023 and May 9, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Excessive Heating” (4 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.

• InjuryMay 9, 2024Excessive Heating; Excessive Heating

  THE CONSUMER SENT AN EMAIL STATING THAT HE PURCHASED A TENS UNIT FROM A CVS IN PHOENIX, AZ. HE USED THE UNIT ONCE AS INSTRUCTED AND WAS TOLD BY THE (B)(6) HOSPITAL THAT HE RECEIVED SECOND DEGREE BURNS. DURING A FOLLOW-UP CALL, THE CONSUMER STATED HIS WIFE BOUGHT THE UNIT FOR HIS BURSITIS. HE STATED IT WAS AMAZING WHAT IT DID WHEN HE FIRST USED THE UNIT FOR HIS BURSITIS. HE STATED THAT AFTER A WHILE HE REMOVED THE UNIT AND HE SAW A BURN SO HE WENT TO THE (B)(6) HOSPITAL, AND THEY GAVE HIM MEDICINE FOR A SECOND DEGREE BURN. HE STATED HE WAS VERY EXCITED ABOUT THE UNIT BUT HESITANT TO USE IT AGAIN. HE STATED HE WAS WALKING OR SITTING DOWN WHEN THE BURN HAPPENED. HE WAS WEARING STRETCHY PANTS OVER THEM LIKE SWEATPANTS. THE PADS WERE PLACED 6-7 INCHES APART FROM ONE ANOTHER. THERE WERE NO OTHER DEVICES NEARBY. HE STATED HE USED THE UNIT FOR ONE ROUND OF 15 MINUTES. HE WAS THE ONLY USER. HE STATED THE EVENT TOOK PLACE ON APRIL 23RD AROUND 5-6 PM. HE WENT TO THE (B)(6) HOSPITAL ON (B)(6). HE WAS USING THE ORIGINAL PADS. HE STATED THE BURN WAS ON HIS RIGHT HIP AND BUTTOCKS RIGHT WHERE THE HIP BONES MEET. HE STATED HE WAS NOT ALLERGIC TO ANYTHING, BUT HE REMEMBERS WHEN HE WAS YOUNG THAT INN

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19283013 ↗
• InjuryMay 6, 2024Excessive Heating; Excessive Heating

  THE CONSUMER SENT AN EMAIL STATING THAT HE PURCHASED A TENS UNIT FROM A CVS IN PHOENIX, AZ. HE USED THE UNIT ONCE AS INSTRUCTED AND WAS TOLD BY THE VA HOSPITAL THAT HE RECEIVED SECOND DEGREE BURNS. DURING A FOLLOW-UP CALL, THE CONSUMER STATED HIS WIFE BOUGHT THE UNIT FOR HIS BURSITIS. HE STATED IT WAS AMAZING WHAT IT DID WHEN HE FIRST USED THE UNIT FOR HIS BURSITIS. HE STATED THAT AFTER A WHILE HE REMOVED THE UNIT AND HE SAW A BURN SO HE WENT TO THE VA HOSPITAL, AND THEY GAVE HIM MEDICINE FOR A SECOND DEGREE BURN. HE STATED HE WAS VERY EXCITED ABOUT THE UNIT BUT HESITANT TO USE IT AGAIN. HE STATED HE WAS WALKING OR SITTING DOWN WHEN THE BURN HAPPENED. HE WAS WEARING STRETCHY PANTS OVER THEM LIKE SWEATPANTS. THE PADS WERE PLACED 6-7 INCHES APART FROM ONE ANOTHER. THERE WERE NO OTHER DEVICES NEARBY. HE STATED HE USED THE UNIT FOR ONE ROUND OF 15 MINUTES. HE WAS THE ONLY USER. HE STATED THE EVENT TOOK PLACE ON APRIL 23RD AROUND 5-6 PM. HE WENT TO THE VA HOSPITAL ON (B)(6). HE WAS USING THE ORIGINAL PADS. HE STATED THE BURN WAS ON HIS RIGHT HIP AND BUTTOCKS RIGHT WHERE THE HIP BONES MEET. HE STATED HE WAS NOT ALLERGIC TO ANYTHING, BUT HE REMEMBERS WHEN HE WAS YOUNG THAT INNER TUBES WOU

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19255487 ↗
• InjuryAug 31, 2023Excessive Heating; Excessive Heating

  THE CONSUMER STATED SHE BOUGHT THE UNIT ON FRIDAY 8/10/2023. SHE PUT THE PADS ON HER LOWER BACK/BUTTOCKS THAT NIGHT AND WOKE UP WITH THE BURNS. SHE STATED IT SEEMED TO BE A FIRST DEGREE BURN AND WAS WAITING IN THE BURN CLINIC WAITING ROOM ON (B)(6) 2023 DURING THE TIME OF THE INITIAL CALL. SHE STATED HER SKIN WAS BUMPY AND SWOLLEN WHERE THE PADS WERE. SHE KEPT STATING THERE WERE VESICLES AND MENTIONED SHE THOUGHT IT WAS A SECOND DEGREE BURN. SHE STATED SHE FOLLOWED THE INSTRUCTIONS SEVERAL TIMES AND STATED THAT THERE IS NOTHING IN THE INSTRUCTIONS THAT STATES SHE MIGHT GET BURNED BY THE UNIT EXCEPT IF SHE WAS USING ANOTHER UNIT, WHICH SHE WAS NOT. SHE STATED IT WAS DEFINITELY AN ELECTRICAL BURN. SHE HAD THE TENS UNIT ON 1 AND STATED IT WAS NOT PAINFUL. SHE STATED SHE WAS DOCTOR AND HAD TO TAKE OFF WORK DUE TO THE BURN. SHE STATED SHE HAD BEEN A DOCTOR FOR 25 YEARS AND STATED IT WAS A SECOND DEGREE BURN. SHE HAD PAIN FOR THREE DAYS AND TINGLING IN HER LEG THAT SHE WAS NOT SURE WAS A RESULT OF THE TENS UNIT. DURING A FOLLOW-UP CALL, THE CONSUMER STATED THAT SHE WAS A DOCTOR. SHE STATED SHE COULD HAVE PERMANENT DAMAGE AND THAT HER INJURY CAN BE A SECOND DEGREE BURN. HER BURN WAS LOOKE

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17667458 ↗
• InjuryAug 29, 2023Excessive Heating; Excessive Heating

  THE CONSUMER STATED SHE BOUGHT THE UNIT ON FRIDAY (B)(6) 2023. SHE PUT THE PADS ON HER LOWER BACK/BUTTOCKS THAT NIGHT AND WOKE UP WITH THE BURNS. SHE STATED IT SEEMED TO BE A FIRST DEGREE BURN AND WAS WAITING IN THE BURN CLINIC WAITING ROOM ON (B)(6) 2023 DURING THE TIME OF THE INITIAL CALL. SHE STATED HER SKIN WAS BUMPY AND SWOLLEN WHERE THE PADS WERE. SHE KEPT STATING THERE WERE VESICLES AND MENTIONED SHE THOUGHT IT WAS A SECOND DEGREE BURN. SHE STATED SHE FOLLOWED THE INSTRUCTIONS SEVERAL TIMES AND STATED THAT THERE IS NOTHING IN THE INSTRUCTIONS THAT STATES SHE MIGHT GET BURNED BY THE UNIT EXCEPT IF SHE WAS USING ANOTHER UNIT, WHICH SHE WAS NOT. SHE STATED IT WAS DEFINITELY AN ELECTRICAL BURN. SHE HAD THE TENS UNIT ON 1 AND STATED IT WAS NOT PAINFUL. SHE STATED SHE WAS DOCTOR AND HAD TO TAKE OFF WORK DUE TO THE BURN. SHE STATED SHE HAD BEEN A DOCTOR FOR 25 YEARS AND STATED IT WAS A SECOND DEGREE BURN. SHE HAD PAIN FOR THREE DAYS AND TINGLING IN HER LEG THAT SHE WAS NOT SURE WAS A RESULT OF THE TENS UNIT.DURING A FOLLOW-UP CALL, THE CONSUMER STATED THAT SHE WAS A DOCTOR. SHE STATED SHE COULD HAVE PERMANENT DAMAGE AND THAT HER INJURY CAN BE A SECOND DEGREE BURN. HER BURN WAS LOOK

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 17646228 ↗