3M™ Nexcare™ 581-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00051131199361), received between Jul 24, 2019 and Aug 3, 2020 — classified as 4 injuries.

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.

• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE CONSUMER REPORTED THAT HE APPLIED REFERENCED BANDAGE TO COVER A WOUND ON HIS LEFT FOREARM (B)(6) 2020. PRIOR TO APPLICATION, NEOSPORIN® WAS APPLIED ON THE WOUND. THE CONSUMER ALLEGED THAT THE BANDAGE WAS DIFFICULT TO REMOVE. THE CONSUMER'S WIFE REPORTEDLY USED BABY OIL TO ASSIST IN REMOVAL. THE BANDAGE WAS REMOVED ON (B)(6) 2020. THE CONSUMER ALLEGED THAT HIS SKIN WAS TORN OFF DURING REMOVAL OF THE LAST BANDAGE PIECE. THE AFFECTED SKIN AREA REPORTEDLY WAS APPROXIMATELY .5" WIDE AND 1" IN LENGTH. THE SKIN AREA WAS ALLEGEDLY PAINFUL AND BLED A LOT. THE CONSUMER APPLIED TWO BANDAGES WITH PADS AND EXTRA GAUZE ON THE AFFECTED AREA. THE CONSUMER REPORTED THAT HE WAS CURRENTLY TAKING CLOPIDOGREL DUE TO A RECENT MINI STROKE. THE CONSUMER REPORTEDLY STOPPED TAKING THE CLOPIDOGREL TO SEE IF THE BLEEDING WOULD STOP. THE BLEEDING REPORTEDLY STOPPED WITHIN A DAY. THE CONSUMER PLACED NEOSPORIN® ON THE WOUND, THEN WRAPPED WITH GAUZE. THE SKIN AREA REPORTEDLY BEGAN TO SLIGHTLY BLEED AGAIN. THE CONSUMER REPORTEDLY WENT BACK ON HIS BLOOD THINNER MEDICATION. HE REPORTED THE SKIN AREA HAD NOT SCABBED OVER. THE CONSUMER VISITED A DERMATOLOGIST. THE DERMATOLOGIST REPORTEDLY SUGGESTED THAT THE CON

  Patient problems: Injury

  MAUDE report 10355638 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MOTHER REPORTED ONE REFERENCED BANDAGE WAS APPLIED TO HER BIRACIAL (CAUCASIAN/AFRICAN-AMERICAN) (B)(6)-YEAR-OLD, AUTISTIC SON'S LEFT ARM TO COVER A RED BOIL ON (B)(6) 2019. THE SON WAS REPORTEDLY BEING TREATED FOR A STAPH INFECTION IN A DIFFERENT AREA PRIOR TO BANDAGE USE. AN OTC WOUND GEL WAS APPLIED TO THE BOIL PRIOR TO APPLICATION. THE BANDAGE WAS REPORTEDLY APPLIED TO CLEAN, DRY SKIN. THE BANDAGE WAS REMOVED THE NEXT MORNING. THE MOTHER ALLEGED APPROXIMATELY 2.5 INCHES OF HER SON'S SKIN WAS PULLED OFF DURING REMOVAL. THE BANDAGE WAS REPORTEDLY REMOVED GENTLY. THE AFFECTED AREA TURNED WHITE AND BEGAN TO BLEED. THE BLEEDING REPORTEDLY STOPPED. THE AFFECTED AREA WAS LEFT OPEN AND UNCOVERED TO AIR OUT. NO OINTMENTS/CREAMS WERE APPLIED. ON (B)(6) 2019 THE MOTHER REPORTED THE AFFECTED AREA WAS HEALING. SHE ALLEGED HER SON'S SKIN WAS STILL HURTING AND BURNING. THE MOTHER TOOK HER SON TO VISIT A DOCTOR ON (B)(6) 2019 . THE DOCTOR PRESCRIBED BACTROBAN OINTMENT. THE MOTHER'S SON WAS REPORTEDLY INSTRUCTED TO KEEP A NON-STICK STERILE PAD, WRAPPED WITH GAUZE, OVER THE AFFECTED AREA. THE SON WAS INSTRUCTED TO CHANGE THE DRESSING ONCE PER DAY. THE DOCTOR REPORTEDLY STATED THE AFFECTED AREA

  Patient problems: Burning Sensation; Injury; Pain

  MAUDE report 8910251 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6)-YEAR-OLD HISPANIC FEMALE CONSUMER APPLIED THE REFERENCED BANDAGE TO COVER A BIOPSY WOUND ON THE FRONT OF HER LEFT ARM, ABOVE THE ELBOW. PRIOR TO APPLICATION, THE WOUND AREA WAS WASHED WITH AN ANTIBACTERIAL SOAP AND ALLOWED TO DRY. TWO DIFFERENT TYPES OF NEXCARE¿ BANDAGES WERE REPORTEDLY USED, SOFT N FLEX AND THE WATERPROOF BANDAGES FOR USE IN THE POOL. THE BANDAGES WERE CHANGED TWICE A DAY, ALTERNATING BETWEEN THE TWO TYPES. THE BANDAGE APPLICATION SITE WAS REPORTEDLY ROTATED DURING CHANGES. THE BANDAGES WERE TYPICALLY WORN FOR 4-6 HOURS. THE CONSUMER REPORTED SHE EXPERIENCED PAIN WHILE REMOVING THE BANDAGES ON THE 2ND DAY OF WEAR. ON THE 3RD DAY OF WEAR, SHE ALLEGED TWO LAYERS OF SKIN WERE PULLED OFF DURING THE REMOVAL OF A NEXCARE¿ WATERPROOF BANDAGE. THE CONSUMER ALLEGED A SKIN REACTION OCCURRED IN THE SHAPE OF THE BANDAGE ADHESIVE. THE AFFECTED AREA REPORTEDLY BLISTERED. THE CONSUMER VISITED AN URGENT CARE. A DOCTOR PRESCRIBED TRIAMCINOLONE ACETONIDE CREAM AND AN OTC TRIPLE ANTIBIOTIC OINTMENT. TWO WEEKS POST-SYMPTOM ONSET THE CONSUMER REPORTED THE AFFECTED AREA HAD HEALED. SHE IS CONTINUING THE PRESCRIBED TREATMENT.

  Patient problems: Injury; Skin Irritation

  MAUDE report 8897285 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR OLD, CAUCASIAN MALE CONSUMER APPLIED THE REFERENCED BANDAGE TO COVER A BED SORE ON HIS LEFT ELBOW ON (B)(6) 2019. PRIOR TO APPLICATION, VITAMIN A&D OINTMENT WAS APPLIED ON THE SORE. THE BANDAGE WAS REMOVED THE FOLLOWING MORNING, (B)(6) 2019. THE MAN ALLEGED A PIECE OF HIS SKIN NEAR THE WOUND, APPROXIMATELY THE SIZE OF .25 INCHES, WAS PULLED OFF DURING REMOVAL. THE AFFECTED AREA BLED. THE CONSUMER REPORTED HE DID NOT HAVE SENSITIVE OR FRAGILE SKIN. THE AFFECTED AREA WAS FLUSHED WITH COLD WATER AND THE BLEEDING STOPPED. THE CONSUMER REPORTED THE WOUND LATER BEGAN TO BLEED AGAIN. HE VISITED A DOCTOR ON (B)(6) 2019. THE DOCTOR PRESCRIBED BACTRIM DS (2X/DAY FOR 10 DAYS) AS A PRECAUTION TO AVOID INFECTION. THE CONSUMER REPORTED THE WOUND STOPPED BLEEDING ON (B)(6) 2019 AND THE AFFECTED AREA APPEARED TO BE HEALING. THE CONSUMER CONTINUED TO APPLY NEOSPORIN AND HYDROGEN PEROXIDE ONTO THE AREA AND COVERED WITH A BANDAGE. ON (B)(6) 2019, THE CONSUMER REPORTED THE WOUND WAS ALMOST COMPLETELY HEALED.

  Patient problems: Skin Tears

  MAUDE report 8822936 ↗