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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 05/26/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 317813309
• Report Number: 3016050930-2023-00004
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 00810010440488
• UDI-Public: 810010440488
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female