MAUDE Adverse Event Report: WELLY HEALTH PBC WELLY BRAVERY ASSORTED CLASSIC VARIETY FLEX FABRIC BANDAGES; ADHESIVE BANDAGES

Model Number	WLY1005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Peeling (1999); Skin Tears (2516); Blister (4537)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, weight, age, race and ethnicity information were not provided.Device was used for treatment, not diagnosis.Device is not expected to be returned for manufacturer review/investigation since it is a single use bandage.Device evaluation/investigation could not be completed.No conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without the lot number.If information is obtained that was not available for the initial med-watch, an additional follow-up med-watch will be filed as appropriate.
Event or Problem Description
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 date, she went to a doctor who advised her to avoid the adhesive that is used in the bandages.This report and the information submitted under this report do not constitute an admission that the device or well health or any of its employees caused or contributed to the event described herein or that the event as reported to well health actually occurred.

• Brand Name: WELLY BRAVERY ASSORTED CLASSIC VARIETY FLEX FABRIC BANDAGES
• Common Device Name: ADHESIVE BANDAGES
• Manufacturer (Section D): WELLY HEALTH PBC; 30 s. 9th street, 7th floor; minneapolis MN 55402
• Manufacturer (Section G): WELLY HEALTH PBC; 30 s. 9th street, 7th floor; minneapolis MN 55402
• Manufacturer Contact: jake schultz ; 30 s. 9th street, 7th floor; minneapolis, MN 55402 ; 6127153303
• MDR Report Key: 13214033
• Report Number: 3016050930-2022-00001
• Device Sequence Number: 5364729
• Product Code: KGX
• UDI-Device Identifier: 00810010440044
• UDI-Public: 00810010440044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: WLY1005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female