3M™ Nexcare™ Active™ 511-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00051131208179), received between Aug 7, 2018 and Jun 11, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE CONSUMER (AGE NOT SPECIFIED) APPLIED ONE BANDAGE, DURING THE MORNING, TO COVER AN UNSPECIFIED STITCHED WOUND ON APPROXIMATELY (B)(6) 2020. THE CONSUMER ALLEGED SHE NOTICED A SKIN REACTION WHEN THE BANDAGE WAS CHANGED IN THE LATE AFTERNOON THAT SAME DAY. EXACT DURATION OF BANDAGE WEAR WAS NOT SPECIFIED. THE CONSUMER IMMEDIATELY STOPPED USING THE BANDAGES AFTER THE ALLEGED REACTION WAS DISCOVERED. THE REACTION WAS DESCRIBED AS REDDENED SKIN, IN THE SHAPE OF A RECTANGLE, AROUND THE INITIAL WOUND AREA. THE AFFECTED AREA REPORTEDLY BECAME REDDER AFTER SHOWERING. THE CONSUMER REPORTED THAT SHE HAS SENSITIVE SKIN, FLOWER ALLERGY AND OTHER UNSPECIFIED ALLERGIES. THE CONSUMER VISITED A DOCTOR ON (B)(6) 2020 TO REMOVE THE EXISTING STITCHES. THE DOCTOR VIEWED THE AFFECTED SKIN AREA AND PRESCRIBED AN RX CORTISONE CREAM. THE DOCTOR REPORTEDLY ADVISED THE CONSUMER THAT IT MAY TAKE SOME TIME FOR THE SKIN AREA TO GO BACK TO NORMAL COLOR.

  Patient problems: Erythema; Skin Irritation

  MAUDE report 10143635 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) AFRICAN-AMERICAN MALE CONSUMER REPORTED HE UNDERWENT A RECENT CYST REMOVAL PROCEDURE. THE CONSUMER PURCHASED AND APPLIED THE REFERENCED BANDAGES TO COVER THE CHEST INCISION WOUND ON (B)(6) 2019. THE CONSUMER'S DOCTOR RECOMMENDED THE INCISION BE KEPT DRY. PRIOR TO APPLICATION, THE INCISION AREA WAS WASHED WITH (B)(6) SOAP AND (B)(6) WAS APPLIED. THE BANDAGES USED WERE CHANGED TWICE DAILY, IN THE MORNING AND NIGHT. EACH BANDAGE WAS WORN FOR APPROXIMATELY 12 HOURS. A TOTAL OF 4 BANDAGES WERE WORN OVER THE COURSE OF TWO DAYS. THE FIRST BANDAGE WAS APPLIED POST-PROCEDURE, LATER IN THE DAY. THE BANDAGE WAS REMOVED THE NEXT DAY. THE CONSUMER ALLEGED HE NOTICED A LITTLE RED MARK ON HIS SKIN AT THIS TIME. THE CONSUMER REPORTED NO KNOWN ALLERGIES. AFTER REMOVAL OF THE FOURTH BANDAGE, ON SECOND DAY OF WEAR, THE CONSUMER ALLEGED HIS SKIN BECAME RED, SCALY, ITCHY, AND STARTED TO DARKEN. HE REPORTED THE REACTION WAS IN THE SHAPE OF THE BANDAGE. THE CONSUMER REPORTED DIFFICULTY REMOVING THE BANDAGES WORN. ON (B)(6) 2019, THE CONSUMER VISITED HIS DOCTOR TO HAVE STITCHES REMOVED. THE CONSUMER REPORTED A PA PRESCRIBED HYDROCORTISONE CREAM 2% TO USE ON THE AFFECTED AREA FOR 7 DAYS. THE CONSU

  Patient problems: Itching Sensation; Skin Irritation

  MAUDE report 8516185 ↗
• InjuryAug 7, 2018Insufficient Device Problem Information

  I EXPERIENCED A SEVERE RASH WITH SKIN LOSS FROM USE OF 3M NEXCARE BANDAGES. THE RASH COVERED SEVERAL SQUARE INCHES OF MY ARM AROUND THE AREA WHERE THE BANDAGE ADHESIVE HAD BEEN TOUCHING MY SKIN. I SUBSEQUENTLY LOST SEVERAL LAYERS OF SKIN IN THAT AREA. THE BANDAGE RASH WAS SIMILAR TO A CHEMICAL BURN. THE BANDAGE RASH COVERED AN AREA AT ABOUT 20 TIMES THE SIZE OF THE THREE ONE INCH LONG SEPARATE LACERATIONS THAT I WAS BANDAGING. THE BANDAGE RASH APPEARED ON ABOUT (B)(6) 2018. AND AS OF (B)(6) 2018, THE BANDAGE RASH HAS STILL NOT COMPLETELY HEALED. THE ADVERSE REACTION OF BANDAGE RASH WAS REPORTED TO 3M NEXCARE IN (B)(6) 2018. AND, SAMPLE BANDAGES WERE MAILED TO 3M NEXCARE ON ABOUT (B)(6) 2018.

  Patient problems: Laceration(s); No Information; Rash; Reaction; Skin Erosion

  MAUDE report 7762360 ↗