MAUDE Adverse Event Report: WELLY HEALTH PBC WELLY BRAVERY BADGES COLORWASH ADHESIVE BANDAGE; TAPE AND BANDAGE, ADHESIVE

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was used for treatment, not diagnosis.Device not returned for manufacturer review/investigation since it is single use bandage.Device evaluation by the manufacturer could therefore not be completed.This report and the information submitted under this report do not constitute an admission that the device or welly health or any of its employees caused or contributed to the event described herein or that the event as reported to welly health occurred.
Event or Problem Description
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.

• Brand Name: WELLY BRAVERY BADGES COLORWASH ADHESIVE BANDAGE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WELLY HEALTH PBC; 700 nicollet mall, suite 800; minneapolis MN 55402
• Manufacturer (Section G): WELLY HEALTH PBC; 700 nicollet mall, suite 800; minneapolis MN 55402
• Manufacturer Contact: joe ciccone ; 700 nicollet mall, suite 800; minneapolis, MN 55402 ; 8565811481
• MDR Report Key: 17195160
• Report Number: 3016050930-2023-00004
• Device Sequence Number: 20244551
• Product Code: KGX
• UDI-Device Identifier: 00810010440488
• UDI-Public: 810010440488
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/23/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female