Aleve 1613538Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00325866565044), received between May 18, 2018 and Apr 22, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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.

• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE STIMULATION ISSUE ('IT FELT LIKE A SHOCK') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED ALEVE TENS DEVICE DIRECT THERAPY UNIT (BATCH NO. T0KZFP) FOR PAIN. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ACCORDING TO THE REPORTER, THE PATIENT HAD NO RELEVANT MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT STARTED ALEVE TENS DEVICE DIRECT THERAPY UNIT. THE DEVICE STIMULATION ISSUE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE MALFUNCTION ("TOUCHED THE + BUTTON ONCE TO INCREASE THE SPEED THEN IT JUST JUMPED TO THE HIGHEST SETTING.") OCCURRED ON AN UNKNOWN DATE. IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH ALEVE TENS DEVICE DIRECT THERAPY UNIT. THE REPORTER COMMENTED: I HAVE THIS FOR ABOUT 3/4 YEARS NOW AND I WAS USING IT LAST NIGHT ON A FEW CYCLES, I TOUCHED THE " +" BUTTON ONCE TO INCREASE THE SPEED THEN IT JUST JUMPED TO THE HIGHEST SETTING. I TOOK IT OFF AT THE VERY MOMENT THEN USED THE REMOTE TO STOP IT. THE CONSUMER ENQUIRES DOES THAT MEAN IT'S NOW DEFECTIVE? MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-APR

  Patient problems: Insufficient Information

  MAUDE report 11710211 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE SITE BURN ('THERE IS ONE LITTLE SECTION ON BACK THAT LOOKS LIKE IT BURNT OFF A COUPLE OF LAYERS OF SKIN/ DOCTOR SAID I HAD 1ST AND POSSIBLY 2ND DEGREE BURNS ON MY BACK') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO RECEIVED ALEVE TENS DEVICE DIRECT THERAPY UNIT (BATCH NUMBER TOLURN) FOR PAIN. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MALFUNCTION "ALEVE TENS UNIT MALFUNCTION". ON AN UNKNOWN DATE, THE PATIENT STARTED ALEVE TENS DEVICE DIRECT THERAPY UNIT. ON 27-DEC-2020, THE PATIENT EXPERIENCED MEDICAL DEVICE SITE BURN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH BLISTER, SKIN WOUND AND PAIN AND MEDICAL DEVICE SITE PAIN ("GOT ALMOST ALL THE WAY THROUGH THE CYCLE AND ALL OF A SUDDEN IT HURTS AS IF I WAS BEING STUNG BY A BUNCH OF BEES"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED SENSORY DISTURBANCE ("NERVE ENDINGS ON BACK ARE NOW SUPER SENSITIVE TO ANY FORM OF HEAT"). THE PATIENT WAS TREATED WITH SULFADIAZINE SILVER (SILVADENE). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE SITE BURN H

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 11552390 ↗
• InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE SITE BURN ("HORRIBLE BURNS/SKIN GOT BURNED AT THE APPLICATION SITE") IN A (B)(6)YEAR-OLD FEMALE PATIENT WHO RECEIVED ALEVE TENS DEVICE DIRECT THERAPY UNIT FOR SCIATICA. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "ALEVE TENS USED FOR SCIATICA PAIN" ON (B)(6) 2018 AND DEVICE MALFUNCTION "DEVICE MALFUNCTION". MEDICAL CONDITIONS: NO CONCOMITANT DRUGS. ON AN UNKNOWN DATE, THE PATIENT STARTED ALEVE TENS DEVICE DIRECT THERAPY UNIT. ON (B)(6) 2018, THE PATIENT EXPERIENCED MEDICAL DEVICE SITE BURN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH MEDICAL DEVICE SITE ERYTHEMA AND MEDICAL DEVICE SITE PAIN. THE PATIENT WAS TREATED WITH NAPROXEN SODIUM (ALEVE CAPLET). AT THE TIME OF THE REPORT, THE MEDICAL DEVICE SITE BURN HAD NOT RESOLVED. THE REPORTER CONSIDERED MEDICAL DEVICE SITE BURN TO BE RELATED TO ALEVE TENS DEVICE DIRECT THERAPY UNIT. THE REPORTER COMMENTED: SCIATICA PAIN DIAGNOSED IN (B)(6) 2018. IT WAS THE FIRST TIME PATIENT USED THE ALEVE TENS. PATIENT CAREFULLY READ THE INSTRUCTIONS. DEVICE PURCHASED ON (B)(6) 2018 AND USED ON THE SAME DAY (30 MINUTES CYCLE DURING TH

  Patient problems: Burn(s)

  MAUDE report 8008538 ↗
• MalfunctionMay 18, 2018Inappropriate/Inadequate Shock/Stimulation

  THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE SITE DISCOLOURATION ("LEAVES MARKS ON MY BACK WHERE IT SHOCKS") IN AN ELDERLY FEMALE PATIENT WHO RECEIVED ALEVE TENS DEVICE DIRECT THERAPY UNIT (UDI NO. (B)(4)). OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE STIMULATION ISSUE "THIS DEVICE LITERALLY SHOCKS ME." (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT STARTED ALEVE TENS DEVICE DIRECT THERAPY UNIT. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED MEDICAL DEVICE SITE DISCOLOURATION. IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH ALEVE TENS DEVICE DIRECT THERAPY UNIT. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE SITE DISCOLOURATION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR MEDICAL DEVICE SITE DISCOLOURATION WITH ALEVE TENS DEVICE DIRECT THERAPY UNIT. QUALITY-SAFETY EVALUATION OF PTC: BASED ON THE TECHNICAL INVESTIGATION, A REVIEW OF THE DEVICE HISTORY FOR THIS SERIAL NUMBER WAS CONDUCTED AND NO DEFECTS WERE IDENTIFIED DURING THE MANUFACTURE OF THE DEVICE. THIS PRODUCT TECHNICAL COMPLAINT CANNOT BE CONFIRMED AT THIS TIME. NO PRODUCT WAS RETURNED. GOOD FAITH ATTEMPTS WER

  Patient problems: Electric Shock; Skin Discoloration

  MAUDE report 7525729 ↗