3M™ Nexcare™ 588-20PBRecalls & reported problems
3M Company · Nexcare™ Waterproof Bandages 588-20PB, Assorted 20 ct · Class 1
All models of 3M Nexcare (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00051131199354), received between Jan 2, 2019 and Nov 20, 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
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Abrasion1
- Blister1
- Burning Sensation1
- Injury1
- Itching Sensation1
- Skin Inflammation/ Irritation1
- Skin Irritation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A (B)(6) YEARS OLD FEMALE CUSTOMER ALLEGED SHE APPLIED THE REFERENCED BANDAGE ON A BIOPSIED WOUND ON HER LEFT ARM ON (B)(6) 2020. THE CUSTOMER STATED SHE WASHED THE AREA WITH DOVE SOAP AND DRIED BEFORE SHE APPLIED THE BANDAGE. SHE REPORTED THAT THE BANDAGE WAS IN PLACE FOR ABOUT 8 TO 12 HOURS. SHE DIDN'T FEEL IRRITATED WHILE WEARING THE BANDAGE, BUT ALLEGED WHEN SHE REMOVED THE BANDAGE, SHE NOTICED THE AREA WAS RED AND WITH RAISED BLISTERS WHERE THE PAD ON THE BANDAGE WAS ON HER SKIN. THE CUSTOMER REPORTED SHE WENT FOR A CHECKUP RELATED TO THE BIOPSY, SO SHE INQUIRED ABOUT THE REACTION FROM THE DERMATOLOGIST. THE DERMATOLOGIST CONFIRMED IT WAS AN ALLERGIC REACTION. THE CUSTOMER REPORTED THAT THE DERMATOLOGIST GAVE HER A CONTACT DERMATITIS CREAM TO USE ON THE AREA. CUSTOMER REPORTED THE AREA LOOKS MUCH BETTER AFTER SHE USED THE CREAM FOR TWO WEEKS. THE CUSTOMER REPORTED SHE USED THE BANDAGE AGAIN ON (B)(6) 2020 ON HER RIGHT ARM WHERE THERE WAS NO WOUND JUST TO SEE IF SHE'LL GET THE SAME REACTION FROM THE BANDAGE. CUSTOMER ALLEGED SHE NOTICED THE SAME REACTION (VERY RAISED, RED AND IRRITATED). CUSTOMER ALLEGED HER RIGHT ARM STILL HAS THE BLISTERS AND STILL ITCHES. SHE HAS BEEN USING
Patient problems: Blister; Burning Sensation; Skin Inflammation/ Irritation
MAUDE report 10878284 ↗InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE CONSUMER APPLIED ONE LARGE SIZED REFERENCED BANDAGE TO COVER A ROUND-SHAPED SORE ON HER RIGHT ELBOW. THE WOUND AREA WAS REPORTEDLY COVERED WITH BAND-AID® BRAND BANDAGES FOR A FEW DAYS PRIOR TO USE. PRIOR TO APPLICATION, THE SKIN AREA WAS RINSED WITH WATER AND NEOSPORIN® WAS APPLIED ON THE WOUND. THE BANDAGE WAS REMOVED 24 HOURS AFTER APPLICATION. THE CONSUMER REPORTED THE BANDAGE WAS EXTREMELY DIFFICULT TO REMOVE. SHE ALLEGED A LAYER OF SKIN WAS TAKEN OFF DURING REMOVAL. REMOVAL TECHNIQUE WAS NOT SPECIFIED. THE AFFECTED AREA WAS REPORTEDLY BRIGHT RED, SORE, RAW, SLIGHTLY BLED AND PAINFUL. NO KNOWN ALLERGIES/SKIN SENSITIVITIES WERE SPECIFIED. THE CUSTOMER VISITED A DOCTOR AND WAS PRESCRIBED MUPIROCIN OINTMENT TO USE ON THE AFFECTED AREA. THE SKIN AREA HEALED.
Patient problems: Injury
MAUDE report 9180383 ↗InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE CONSUMER (AGE NOT SPECIFIED) APPLIED THE REFERENCED BANDAGES TO COVER TWO SMALL WOUNDS ON HER RIGHT HAND BETWEEN HER WRIST AND FINGERS. PRIOR TO APPLICATION, THE CONSUMER WASHED HER HANDS WITH ANTIBACTERIAL SOAP AND ALLOWED THEM TO DRY. THE CONSUMER ALSO APPLIED A SMALLER SIZED REFERENCED BANDAGE OVER A SMALL WOUND ON HER LEFT HAND. THE BANDAGES WERE APPLIED ON (B)(6) 2019 AND WORN FOR APPROXIMATELY 5-6 HOURS. THE CONSUMER REPORTED THE BANDAGES WERE DIFFICULT TO REMOVE. THE CONSUMER REPEATEDLY PULLED THE BANDAGE CORNERS UP TO REMOVE. DURING REMOVAL, THE CONSUMER ALLEGED THE BANDAGES REMOVED THREE LARGE SPOTS OF SKIN ON HER RIGHT HAND. SHE REPORTED THE SPOTS OCCURRED AT THE BANDAGE ADHESIVE LOCATION. DURING THE REMOVAL OF THE SMALLER BANDAGE, THE CONSUMER ALLEGED ONE SKIN AREA ON HER LEFT HAND WAS REMOVED. SHE REPORTED THE AFFECTED AREAS LOOKED RAW AND BLED. THE CONSUMER CLEANED THE AFFECTED AREAS AND APPLIED MANUAL PRESSURE TO STOP THE BLEEDING. THE CONSUMER REPORTED SHE IS A DIABETIC AND VISITED HER DOCTOR ON (B)(6) 2019, DUE TO THE AFFECTED AREAS STARTING TO LOOK RED. THE DOCTOR PRESCRIBED AN UNSPECIFIED ANTIMICROBIAL CREAM AND AN ANTIBIOTIC, CEPHALEXIN 500MG. ON (B)(6)
Patient problems: Abrasion
MAUDE report 8565714 ↗InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE CUSTOMER REPORTED SHE CUT HER LEFT THUMB ON (B)(6) 2018, WITH A KNIFE. SHE INITIALLY APPLIED NON-3M BRAND BANDAGES TO THE CUT AS IT HEALED. ON (B)(6) 2018, THE WOMAN COVERED THE CUT WITH ONE OF THE REFERENCED BANDAGES. THE BANDAGE WAS REMOVED, WITHOUT DIFFICULTY, AFTER 36 HOURS OF WEAR. DURING THE MORNING OF (B)(6) 2018, A SECOND BANDAGE WAS APPLIED TO THE WOUND AREA AFTER SHOWERING. NO TOPICAL OINTMENT WAS APPLIED TO THE CUT. THE BANDAGE WAS WORN FOR 48 HOURS. THE WOMAN ALLEGED WHEN SHE WOKE UP THE MORNING OF (B)(6) 2018, HER THUMB WAS HURTING. THE WOMAN ALLEGED SHE ATTEMPTED TO REMOVE THE BANDAGE BY HAND, BUT HAD DIFFICULTY. THE BANDAGE WAS REMOVED USING SCISSORS. UPON REMOVAL, SHE ALLEGED HER THUMB WOUND AREA WAS RED, BURNING, AND ITCHY. NEOSPORIN WAS APPLIED TO THE AREA. NO KNOWN ALLERGIES WERE SPECIFIED. DURING THAT SAME EVENING, SHE ALLEGED FEELING LIKE A BLISTER WAS FORMING. SHE ALLEGED HER THUMB THROBBED AND WAS PAINFUL. THE WOMAN ALLEGED DISCOVERING A BLISTER FORMED, JUST BELOW HER NAIL BED AND ON HER THUMB PAD, THE MORNING OF (B)(6) 2018. SHE ALLEGED HER SKIN IN THE AREA LOOKED RED AND THE BLISTERS WERE SOMEWHAT YELLOW IN COLOR. SHE ALLEGED EXPERIENCING SOME ITC
Patient problems: Itching Sensation; Skin Irritation
MAUDE report 8209868 ↗
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- CURAD NON25650QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall1 report
- 3M™ 1500U3m Company · Tape and bandage, adhesive1 recall1 report
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- 3M™ Durapore™ 1538-1183M Deutschland GmbH · Tape and bandage, adhesive1 recall0 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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