Welly WLY1045Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810010440488), received between Sep 22, 2021 and Jun 23, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 02-JUN-2023, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A FEMALE (AGE NOT PROVIDED) WHO WAS USING A WELLY BRAVERY BADGES COLORWASH ADHESIVE BANDAGE. ON APPROXIMATELY (B)(6) 2023, AFTER TAKING A SHOWER AND CLEANING THE CUT, THE CONSUMER TOPICALLY APPLIED A BRAVERY BADGES ASSORTED COLORWASH BANDAGE TO THE CUT ON THE LEG OVERNIGHT. THE NEXT MORNING, WHEN SHE REMOVED THE BANDAGE A CHUNK OF HER SKIN HAD BEEN REMOVED AS WELL. TWO DAYS LATER SHE DEVELOPED A WOUND ON HER LEG. IT WAS RED AND "INFECTED LOOKING". FOR TREATMENT, SHE APPLIED NEOSPORIN. AS OF (B)(6) 2023, SHE WAS STARTING TO HEAL AND SHE THOUGHT SHE WOULD HAVE A SCAR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abrasion

  MAUDE report 17195160 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL FROM A CONSUMER REGARDING A (B)(6) FEMALE WHO USED WELLY BRAVERY BADGES COLORWASH ADHESIVE BANDAGES. MEDICAL HISTORY INCLUDED PRIOR USE OF SEVERAL BRANDS OF BAND-AIDS (NON-COMPANY) WITHOUT INCIDENT. THE CONSUMER WAS HEALTHY AND HAD NO KNOWN ALLERGIES. NO CONCOMITANT PRODUCTS WERE REPORTED. ON (B)(6) 2021, THE CONSUMER TOPICALLY APPLIED 3 WELLY BRAVERY BADGES COLORWASH ADHESIVE BANDAGES (LOT NUMBER AND EXPIRATION DATE NOT PROVIDED) TO HER LEFT HEEL, HER SECOND TOE, AND ONE ON THE BACK OF HER RIGHT LEG. THE NEXT DAY, SHE HAD AN ALLERGIC REACTION IN ALL THREE LOCATIONS WERE THE "BAND-AIDS" (REPORTER PRODUCT DESCRIPTION, HEREAFTER REFERRED TO AS "BANDAGES") WERE APPLIED. ON (B)(6) 2021 IT WAS CLARIFIED THAT THE MORNING AFTER THE APPLICATION OF THE BANDAGES THERE WAS NO ADVERSE EVENT(S) NOTED BEFORE THE CHILD WENT TO DAYCARE. WHEN THE CHILD RETURNED FROM DAYCARE AT APPROXIMATELY 5 P.M. THE SAME DAY, SHE HAD DEVELOPED SMALL AND LARGE BLISTERS ON EVERY BANDAGE APPLICATION SITE. HER PARENT WAS A HEALTHCARE PRACTITIONER WHO KEPT THE AREAS CLEAN AND DRY. TOPICAL ANTIBIOTIC OINTMENT WAS APPLIED TO THE SITES. TH

  Patient problems: Bacterial Infection; Blister; Hypersensitivity/Allergic reaction; Pain; Scar Tissue; Skin Tears

  MAUDE report 12514420 ↗