Welly WLY1005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810010440044), received between Jan 10, 2022 and Jan 11, 2022 — 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.

• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 17-DEC-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL FROM A CONSUMER REGARDING A (B)(6) MALE WHO HAD A WELLY BRAVERY BADGES ASSOCIATED ASSORTED CLASSIC VARIETY FLEX FABRIC BANDAGE APPLIED. THE CONSUMER HAD NO KNOWN DRUG ALLERGIES. THE CONSUMER DID NOT HAVE ANY KNOWN MEDICAL HISTORY. NO CONCOMITANT PRODUCTS WERE USED. ON (B)(6) 2021, A WELLY BRAVERY BADGES ASSOCIATED ASSORTED CLASSIC VARIETY FLEX FABRIC BANDAGE WAS TOPICALLY APPLIED TO THE CHILD'S LEFT LOWER CHEEK/CHIN AREA FOR AN UNSPECIFIED INDICATION. AFTER 24-HOURS OF BANDAGE APPLICATION, WHILE THE BANDAGE WAS BEING REMOVED A PORTION OF THE CHILD'S SKIN WAS PEELED OFF IN THE SHAPE OF THE BANDAGE FROM THE RIGHT SIDE OF THE ADHESIVE PORTION OF THE BANDAGE. THE CHILD BLEED FROM THE INJURY. THE REPORTER NOTED THE BANDAGE WAS SOAKED WHILE HE WAS BATHING PRIOR TO PULING IT FROM HIS SKIN. FOR TREATMENT OF HIS SYMPTOMS AN OTC (OVER-THE-COUNTER) ANTIBIOTIC CREAM WAS APPLIED AND THE AREA WAS FURTHER BANDAGED. AS OF (B)(6) 2021, THE INJURY WAS HEALING AND IT WAS UNCERTAIN IF THERE WOULD BE ANY SCARRING. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT C

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Tears

  MAUDE report 13227084 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 13-DEC-2021, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A FEMALE (AGE NOT PROVIDED) WHO USED TWO WELL ASSORTED CLASSIC VARIETY FLEX FABRIC BANDAGES. MEDICAL HISTORY INCLUDED SENSITIVE SKIN AND SMALL CUTS ON THE UPPER THIGH OF HER LEG. THE CONSUMER HAD "ALLERGIES TO MOST BANDAGES" AND SHE "HAD QUITE A FEW ALLERGIES". CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED TWO WELL ASSORTED CLASSIC VARIETY FLEX FABRIC BANDAGES (LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED) OVER SMALL CUTS ON THE UPPER THIGH OF HER LEG. A FEW HOURS AFTER THE CONSUMER APPLIED THE WELL ASSORTED CLASSIC VARIETY FLEX FABRIC BANDAGES, IT BEGAN TO FEEL EXTREMELY ITCHY. AFTER SHE SLOWLY REMOVED THE BANDAGES, SHE WAS SHOCKED TO FIND THAT THE FABRIC OF THE BANDAGES CAUSED AN ALLERGIC REACTION. SHE HAD ONE OF THE MOST SEVERE REACTIONS SHE EVER HAD FROM A BANDAGE. HER SKIN PEELED UP, BLISTERED, AND RIPPED OFF WITH THE BANDAGE WHEN SHE CAREFULLY REMOVED IT. SHE EXPERIENCED MORE PAIN, AND IT CAUSED THE ENTIRE TOP HALF OF HER LEG TO HAVE RAW SKIN COMPARED TO THE ORIGINAL SMALL CUTS SHE ORIGINALLY USED THE BANDAGES FOR. ON AN UNSPECIFIED

  Patient problems: Blister; Hypersensitivity/Allergic reaction; Pain; Peeling; Skin Tears

  MAUDE report 13214033 ↗