3M NexcareRecalls & reported problems across all models
3M Company · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 0
We found 10 models of 3M Nexcare by 3M Company in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jan 2, 2019 and Jan 11, 2023 — classified as 20 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported 3M Nexcare problems
Device problems
- Adverse Event Without Identified Device or Use Problem15
- Patient Device Interaction Problem7
Patient problems
- Skin Irritation8
- Skin Inflammation/ Irritation6
- Erythema5
- Rash5
- Blister4
- Injury4
- Itching Sensation4
- Burning Sensation3
3M Nexcare models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 3M™ Nexcare™ 588-20PBTape and bandage, adhesive4 reports
- 3M™ Nexcare™ 581-08Tape and bandage, adhesive4 reports
- 3M™ Nexcare™ 432-50Tape and bandage, adhesive3 reports
- 3M™ Nexcare™ 779Tape and bandage, adhesive2 reports
- 3M™ Nexcare™ 732Tape and bandage, adhesive2 reports
- 3M™ Nexcare™ 731Tape and bandage, adhesive1 report
- 3M™ Nexcare™ 771-1PKTape and bandage, adhesive1 report
- 3M™ Nexcare™ 771-2PKTape and bandage, adhesive1 report
- 3M™ Nexcare™ SSB-20ATape and bandage, adhesive1 report
- 3M™ Nexcare™ 432-100Tape and bandage, adhesive1 report
Recent 3M Nexcare adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
A FEMALE CUSTOMER (AGE UNSPECIFIED) REPORTED AN INCIDENT REGARDING THE NEXCARE¿ STRONG HOLD PAIN FREE REMOVAL BANDAGES. ON AN UNSPECIFIED DATE, A MOLE WAS REMOVED FROM HER ABDOMEN. ON (B)(6) 2022, SHE APPLIED THE NEXCARE BANDAGE ON HER ABDOMEN COVERING THE INCISION. THE BANDAGE WAS IN PLACE FOR ABOUT FOUR TO FIVE HOURS. WHILE THE BANDAGE WAS IN PLACE, THE AREA WAS ITCHY. AFTER SHE REMOVED THE BANDAGE, SHE ALLEGEDLY NOTICED A RED LINE WHERE THE BANDAGE PAD WAS PLACED. THE AREA WAS ALLEGEDLY BLOTCHY AND ITCHY. SHE ALLEGED THE REDNESS SPREAD ROUGHLY 5"X10" FROM WHERE THE PAD TOUCHED HER SKIN. THE REDNESS WAS ALLEGEDLY ONLY ON THE RIGHT SIDE OF HER ABDOMEN. ON UNSPECIFIED DATE, SHE SENT THE PICTURES OF THE ALLEGED INJURY TO HER DERMATOLOGIST. THE DERMATOLOGIST PRESCRIBED AN UNSPECIFIED STEROID CREAM. SHE APPLIED THE CREAM TWICE A DAILY AND PLACED ICE ON THE AREA. ON AN UNSPECIFIED DATE, THE INFLAMMATION STARTED TO DECREASE. HER DOCTOR SAID THAT IT WILL BE A WHILE BEFORE THE ALLEGED INJURY COMPLETELY RESOLVED. ON (B)(6) 2023, THE CUSTOMER ALLEGED THE OUTLINE OF THE PAD AND INFLAMED ITCHY AREAS ON HER SKIN WERE STILL VISIBLE AFTER THREE WEEKS OF USING THE PRESCRIBED STEROID CREAM TWICE D
Patient problems: Rash; Skin Inflammation/ Irritation
MAUDE report 16142183 ↗InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
A MALE CUSTOMER (AGE UNSPECIFIED) REPORTED AN INCIDENT REGARDING THE NEXCARE ABSOLUTE WATERPROOF TAPE. HE USED THE TAPE TO SECURE A FOOT SOCK. ON (B)(6) 2022, HE ALLEGED THE TAPE CAUSED BLISTERS AND SEVERE SKIN RASH ON THE AREA. NO ADDITIONAL INFORMATION PROVIDED. NO ALLERGIES, MEDICAL HISTORY INTERVENTION REPORTED.
Patient problems: Blister; Rash
MAUDE report 15911595 ↗InjuryOct 5, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
A FEMALE CUSTOMER (AGE UNSPECIFIED) REPORTED AN INCIDENT REGARDING THE NEXCARE¿ FLEXIBLE CLEAR FIRST AID TAPE. ON AN UNSPECIFIED DATE, THE BANDAGE WAS APPLIED OVER ANOTHER BRAND OF BANDAGE COVERING A DRAINING SORE (TYPE OF DRAINAGE WAS NOT REPORTED) ON HER ANKLE (EXACT LOCATION WAS REPORTED). A COUPLE OF DAYS LATER, SHE ALLEGEDLY BROKE OUT IN A RASH ON HER STOMACH, CHIN, ARMS AND THE BACK OF HER EARS. SHE ALLEGED HER LOWER ARM WAS ALSO SLIGHTLY SWOLLEN. ON AN UNSPECIFIED DATE, THE DOCTOR PRESCRIBED TRIAMCINOLONE ACETONIDE OINTMENT USP 0.1% FOR THE RASH. NO ALLERGIES, MEDICAL HISTORY OR INTERVENTION REPORTED.
Patient problems: Rash; Skin Inflammation/ Irritation
MAUDE report 12577078 ↗InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A MALE CUSTOMER (AGE UNSPECIFIED) REPORTED AN INCIDENT REGARDING THE NEXCARE¿ ABSOLUTE WATERPROOF TAPE. HE ALLEGED THE TAPE CAUSED 2ND DEGREE BURNS AND LEFT RAISED BLISTERS ON HIS SKIN. HE APPLIED THE TAPE AT ABOUT 10 PM ON WEDNESDAY (B)(6) 2021 ON HIS RIGHT UNDERARM. HE WAS COVERING A SURGICAL INCISION. HE APPLIED ANTIBIOTIC CREAM ON THE WOUND, GAUZE AND THEN TAPED THE EDGES WITH THE TAPE. HE ALLEGED HE FELT BURNING AND ITCHING UNDER THE TAPE. THE TAPE WAS REMOVED THE MORNING OF (B)(6) 2021. THE TAPE WAS NOT DIFFICULTY TO REMOVE. HE ALLEGED THE AREA WAS RED, PAINFUL AND BLED WHEN HE REMOVED THE TAPE. HE ALLEGED HE WASHED THE AREA WITH WATER AND THE REDNESS TURNED INTO BLISTERS. THE ALLEGED INJURY WAS ONLY IN THE AREA WHERE THE TAPE WAS APPLIED ON HIS SKIN. HE FOLLOWED UP WITH HIS DOCTOR ON THURSDAY (B)(6) 2021 AND THE DOCTOR PRESCRIBED AN ANTIBIOTIC (TYPE WAS NOT SPECIFIED) FOR THE SURGICAL WOUND (NOT FOR THE ALLEGED BLISTERS). ON (B)(6) 2021, HE WENT TO THE DERMATOLOGIST, WHO ALLEGED THE INJURY IS A CHEMICAL BURN AND PRESCRIBED 1% SILVER SULFADIAZINE CREAM TO APPLY ON THE AREA. HE ALLEGED IT HURTS EVERY TIME HE MOVES HIS ARM OR GETS HIS ARM WET. HE IS WORRIED THE AREA MAY GET INF
Patient problems: Blister; Burning Sensation; Pain; Skin Inflammation/ Irritation
MAUDE report 11808987 ↗InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE CUSTOMER ALLEGED THAT HER 10 YEARS OLD DAUGHTER HAD A SEVERE ALLERGIC REACTION TO THE NEXCARE WATERPROOF BANDAGES. HER DAUGHTER HAD A WART INFECTION. SHE APPLIED AN OVER THE COUNTER WART MEDICINE (MEDICATION UNSPECIFIED) TO THE AREA BEFORE SHE APPLIED THE NEXCARE BANDAGE. ONE BANDAGE WAS APPLIED TO HER RIGHT KNEE AND ANOTHER BANDAGE WAS APPLIED TO HER RIGHT INNER THIGH. SHE USED THE BANDAGE FOR 3 CONSECUTIVE DAYS. THE BANDAGE WAS IN PLACE FOR ABOUT 16-24 HOURS AND WAS CHANGED DAILY. SHE FIRST NOTICED THE ALLEGED INJURY ON (B)(6) 2021. SHE ALLEGED THE AREA WAS RED, BUBBLY AND LOOKED LIKE A BLISTER. SHE TREATED THE AREAS WITH A STEROID CREAM (TRIAMCINOLONE ACETONITE OINTMENT) THAT WAS PRESCRIBED BY THE DOCTOR. THE ALLEGED INJURY IS RESOLVING. SHE REPORTED THAT HER DAUGHTER IS ALLERGIC TO HAY FEVER AND HAD A PAST ALLERGIC REACTION TO LATEX TAPE AFTER ROUTINE INFANT IMMUNIZATION. NO MEDICAL HISTORY REPORTED.
Patient problems: Blister; Local Reaction; Skin Inflammation/ Irritation
MAUDE report 11546393 ↗InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE CUSTOMER (AGE UNSPECIFIED) ALLEGED THE NEXCARE CLEAR WATERPROOF BANDAGES CAUSED RASH TO HER BACK (EXACT LOCATION UNSPECIFIED). THE CUSTOMER STATED SHE HAD A SURGICAL PROCEDURE DONE ON HER BACK ON (B)(6) 2020, AND SHE WAS INSTRUCTED BY THE DOCTOR TO CLEANSE THE SURGICAL AREA (CUSTOMER DID NOT SPECIFY WHAT WAS USED TO CLEAN AREA), APPLY VASELINE AND COVER WITH BANDAGE. THE CUSTOMER STATED SHE CHANGED THE BANDAGE EVERY NIGHT. THE CUSTOMER ALLEGED SHE NOTICED THE RASH 72 HOURS AFTER APPLYING THE BANDAGE. SHE STATED THE FIRST COUPLE OF DAYS SHE USED THE BANDAGE, SHE WASN'T SURE IF IT WAS THE BANDAGE THAT WAS IRRITATING HER OR IF IT WAS THE SURGICAL WOUND. THE CUSTOMER REPORTED SHE INSTRUCTED HER HUSBAND TO USE RUBBING ALCOHOL AND LOTION TO SOOTHE THE ALLEGED INJURY AREA. SHE ALLEGED THE RASH IS ABOUT 6 BY 6 INCHES BEYOND THE AREA WHERE THE BANDAGE TOUCHED HER SKIN. THE CUSTOMER ALLEGED THE DOCTOR PRESCRIBED MOMETASONE 1% FOR THE ALLEGED RASH. THE CUSTOMER REPORTED SHE'S ALLERGIC TO LATEX, CODEINE, IODINE AND SALSA RUGS. NO MEDICAL HISTORY REPORTED.
Patient problems: Rash; Skin Inflammation/ Irritation
MAUDE report 10905161 ↗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 ↗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 ↗InjuryJul 29, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
THE (B)(6) YEAR OLD CAUCASIAN MALE CUSTOMER REPORTED THAT HE APPLIED THE REFERENCED TAPE, IN THE EVENING, ON THE BACK OF HIS CALF AREA TO SECURE GAUZE OVER A WOUND. PRIOR TO APPLICATION, NEOSPORIN® WAS APPLIED ON THE WOUND AREA. THE CUSTOMER REPORTED THAT THE WOUND WAS A PRECANCEROUS SKIN AREA WHICH HAD RECENTLY BEEN FROZEN, TURNED INTO A LIQUID BUBBLE AND BURST. THE TAPE WAS APPLIED ONCE AND WORN FOR SEVERAL HOURS. THE CUSTOMER ALLEGED THAT HE NOTICED A SKIN REACTION HAD OCCURRED DURING TAPE REMOVAL THE FOLLOWING MORNING. HE ALLEGED A SEVERE ALLERGIC REACTION WAS VISIBLE EVERYWHERE THE TAPE TOUCHED HIS SKIN. HE ALLEGED THAT THE SKIN AREA AT THE TAPE APPLICATION SITE TURNED BRIGHT RED, SWELLED APPROXIMATELY 0.5-0.7 MM HIGH AND OOZED LIQUID. THE CUSTOMER REPORTED THAT HE HAD ALLERGIES TO MULTIPLE, UNSPECIFIED CHEMICALS. HE REPORTEDLY EXPERIENCED SWELLING IN PAST WITH BEE INTERACTIONS AND EXPERIENCED SKIN REACTIONS FROM SPIDER BITES. THE CUSTOMER VISITED A DERMATOLOGIST FOR THE REPORTED SYMPTOMS. THE DOCTOR PRESCRIBED CLOBETASOL PROPIONATE CREAM 0.05% TO USE FOR SEVERAL WEEKS. THE DOCTOR REPORTEDLY ADVISED THE CUSTOMER THAT THE SYMPTOMS COULD LAST ANYWHERE FROM 4-6 WEEKS. THE CUSTOME
Patient problems: Erythema; Skin Irritation; Swelling
MAUDE report 10338610 ↗InjuryJul 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
A MALE CUSTOMER FIRST APPLIED THE REFERENCED TAPE IN TWO CROSSING STRIPS OVER HIS TWISTED KNEE ON (B)(6) 2020. THE TAPE WAS REMOVED THAT SAME EVENING, REPORTEDLY WITH NO ISSUES. THE CUSTOMER APPLIED THE TAPE AGAIN AROUND HIS KNEE THE EVENING OF (B)(6) 2020. THE CUSTOMER ALLEGED THAT THE TAPE WAS REMOVED THE FOLLOWING MORNING DUE TO HIM EXPERIENCING ITCHING AND SKIN REDNESS. A BIG BLISTER ALLEGEDLY DEVELOPED ABOVE HIS KNEE. TWO ADDITIONAL BLISTERS LATER DEVELOPED ON HIS KNEE AND ONE BELOW. THE BLISTERS REPORTEDLY MEASURED APPROXIMATELY .5"-1" IN WIDTH. THE CUSTOMER REPORTED ALLERGIES TO COMPOUNDS WITH ORGANIC MERCURY. NO OTHER KNOWN ALLERGIES WERE SPECIFIED. THE CUSTOMER REPORTED THAT THE REACTION LOOKED SIMILAR TO ALLERGIC REACTIONS HE EXPERIENCED IN THE PAST. HE APPLIED A COOL DAMP WASHCLOTH ON THE SKIN AREAS AND ELEVATED HIS LEG. THE CUSTOMER VISITED A DOCTOR ON (B)(6) 2020. THE DOCTOR REPORTEDLY DIAGNOSED THE AFFECTED SKIN AREA AS HIVES. THE DOCTOR PRESCRIBED AN UNSPECIFIED TOPICAL OINTMENT TO BE APPLIED TWICE DAILY AND RECOMMENDED THE CUSTOMER TAKE OTC ZYRTEC®. THE CUSTOMER ALSO TOOK OTC BENADRYL® TO TREAT SYMPTOMS.
Patient problems: Erythema; Itching Sensation; Skin Irritation
MAUDE report 10307553 ↗InjuryJul 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
A MALE CUSTOMER REPORTED THAT HE APPLIED THE REFERENCED TAPE TO SECURE A CATHETER TO HIS INNER RIGHT THIGH ON (B)(6) 2020. THE TAPE WAS REPORTEDLY WORN WHILE LAYING DOWN AND DURING SHOWERS/BATHS. THE CUSTOMER REPORTED THAT HE INITIALLY USED DIFFERENT TAPE BRAND FOR SECUREMENT WITHOUT ANY ISSUES. PRIOR TO APPLICATION THE CUSTOMER SHOWERED, THEN ALLOWED THE SKIN AREA TO DRY. THE TAPE WAS WORN FOR A COUPLE OF HOURS. EXACT DURATION OF WEAR WAS NOT SPECIFIED. THE CUSTOMER ALLEGED THAT HIS THIGH BEGAN TO GET RED, BUMPY AND ITCHY DURING WEAR. THE REACTION WAS REPORTEDLY IN THE SHAPE OF THE TAPE ADHESIVE. NO KNOWN ALLERGIES OR SKIN SENSITIVITIES WERE SPECIFIED. THE CUSTOMER APPLIED THE TAPE FOR THE NEXT TWO DAYS, WHILE SHOWERING, FOR A COUPLE OF HOURS EACH WEAR. THE SKIN AREA REPORTEDLY WORSENED AND BECAME REDDER DURING THIS TIME FRAME. TINY BLISTERS ALLEGEDLY FORMED ON THE SKIN. THE CUSTOMER VISITED A DOCTOR ON (B)(6) 2020. THE DOCTOR REPORTEDLY ADVISED THE CUSTOMER THE SKIN REACTION WAS CAUSED BY THE TAPE ADHESIVE AND PRESCRIBED HYDROCORTISONE CREAM. THE CUSTOMER SWITCHED TO USING PAPER TAPE. THE AFFECTED SKIN AREA REPORTEDLY IMPROVED.
Patient problems: Erythema; Itching Sensation; Skin Irritation
MAUDE report 10264530 ↗InjuryFeb 10, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
A CONSUMER REPORTED VIA AN ONLINE REVIEW THAT THEY APPLIED THE REFERENCED TAPE. DATE, DURATION AND LOCATION OF WEAR WERE NOT SPECIFIED. THE TAPE WAS REPORTEDLY USED TO SECURE GAUZE. THE CONSUMER ALLEGED THEY DEVELOPED CONTACT DERMATITIS DUE TO TAPE USE. NO KNOWN ALLERGIES/SKIN SENSITIVITIES WERE SPECIFIED. THE CONSUMER REPORTED THEY USED PREDNISONE TO TREAT THE REACTION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Itching Sensation; Skin Irritation
MAUDE report 9686583 ↗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 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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