Welly WLY1043Recalls & reported problems

Welly Health Pbc · First Aid Kit - Adventure 130ct · Class N

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00372663000056), received between May 4, 2022 and May 4, 2022 — classified as 1 injury.

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

Appropriate Device Problem Term/Code Not Available1

Patient problems

Erythema1
Pain1
Skin Tears1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL FROM A CONSUMER REGARDING A (B)(6) FEMALE WHO USED WELLY BRAVERY KIT-BANDAGES. MEDICAL HISTORY INCLUDED ATTENTION DEFICIT HYPERACTIVITY DISORDER AND A SMALL BUMP ON HER SIDE WHICH SHE THOUGHT IT MIGHT HAVE BEEN AN INGROWN HAIR. IT WAS NOT AN OPEN AREA. THE BUMP WAS WHERE HER BRA WAS WHICH WOULD RUB ON THE AREA. ALLERGIES INCLUDED TRAMADOL. CONCOMITANT PRODUCTS INCLUDED ADDERALL (MIXED AMPHETAMINE SALTS). ON APPROXIMATELY (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED THE BANDAGE TO THE SMALL BUMP ON HER SIDE. SHE APPLIED THE LARGE WELLY BANDAGE FOR PADDING, SO HER BRA WOULD NOT RUB ON THE AREA. SHE REALIZED IT WAS NOT THE INTENDED USE FOR THE BANDAGE, BUT SHE THOUGHT IT WOULD GIVE HER A LITTLE PADDING. SHE THEN WORKED OUTSIDE THAT DAY. APPROXIMATELY TWELVE HOURS AFTER THE CONSUMER APPLIED THE BANDAGE, IT TOOK HER SKIN OFF WHEN SHE WENT TO TAKE IT OFF. IT WAS HARD TO REMOVE, AND HER HUSBAND PULLED IT OFF. THE BANDAGE PEELED SOME OF HER SKIN OFF UPON REMOVAL. IT WAS VERY PAINFUL TO REMOVE, AND IT CAUSED REDNESS AT THE SITE. SHE HAD A HUGE SECTION ON HER SIDE WHICH WAS MISSING A LAYER OF SKIN. SHE CONTACTE
Patient problems: Erythema; Pain; Skin Tears
MAUDE report 14279775 ↗

Device details

UDI-DI	`00372663000056`
Brand	Welly
Model	WLY1043
Company	Welly Health Pbc
Product code	LRR · First Aid Kit With Drug
Class	Class N
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 9, 2020

Device type (GMDN): First aid kit, medicated

A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.

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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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