MAUDE Adverse Event Report: WELLY HEALTH PBC WELLY BRAVERY KIT; ADHESIVE BANDAGES

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Pain (1994); Skin Tears (2516)

Event Date 04/09/2022

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device not returned for manufacturer review/investigation since it is a single use bandage.Device evaluation by manufacturer could therefore not be completed.No conclusion could be drawn as the product was not returned to the manufacturer for evaluation.Device history records review could not be completed without the product lot number.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 actually occurred.

Event Description

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 contacted her health care practitioner who told her apply neosporin and cover it with gauze.Then it would heal okay.She was told to follow up if there were any signs of infection.It was extremely painful to move or have anything touch the area.She had never had sensitivities or allergies prior to this happening.As of (b)(6) 2022, she was better, but she still had a little redness and pain.She threw the kit away.She no longer had the product and was not able to provide additional information about the bandage.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 actually occurred.

• Brand Name: WELLY BRAVERY KIT
• Type of Device: 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: 14279775
• MDR Text Key: 290660217
• Report Number: 3016050930-2022-00006
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 00372663000056
• UDI-Public: 372663000056
• 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: Other
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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
• Date Manufacturer Received: 04/11/2022
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ADDERALL (MIXED AMPHETAMINE SALTS)
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female