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

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Scar Tissue (2060); Skin Tears (2516)

Event Date 07/01/2022

Event Type  Injury  

Event Description

On 15-dec-2022, a spontaneous report from the united states was received via email regarding a female (age not provided) consumer who used a welly heroic bandage kit.Medical history included allergies to "medical" adhesives which cause localized itching and redness after a day or two of continuous use and a pimple on the breast.The consumer noted she did not have sensitive or delicate skin.Further medical history and concomitant product usage were not provided.On an unspecified date in (b)(6) 2022, the consumer topically applied a heroic bandage to cover over a pimple on her breast.On 19-dec-2022, additional information was received from the consumer.On 30-dec-2022, additional information was received from a consumer via the fda (mw5113868).Approximately after 12 hours of applying a heroic bandage on (b)(6) 2022, the consumer experienced cellulitis which she needed treatment for.It was clarified that when she removed the bandage, approximately a 1 cm square area of epidermis was torn off by the bandage which was not at the location of the original pimple.She had difficulty keeping the wound covered and it became infected.On an unspecified date in 2022, the consumer had a telemedicine visit with a doctor and she showed her photos of the wound.She was diagnosed with cellulitis and was treated with mupirocin and a course of cephalexin.The wound healed but it left a large scar.No additional information was provided.The reporter also provided information regarding the associated case: (b)(4).

Manufacturer Narrative

Information regarding associated case (b)(4) was also provided by the fda (mw5113868).Device was used for treatment, not diagnosis.Device not returned for manufacturer review/investigation since it is single use bandage.Device evaluation by 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.

• Brand Name: WELLY HEROIC BANDAGE 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: joe ciccone ; 30 s. 9th street, 7th floor; minneapolis, MN 55402 ; 8565811481
• MDR Report Key: 16126777
• MDR Text Key: 306981911
• Report Number: 3016050930-2023-00001
• Device Sequence Number: 1
• Product Code: KGX
• 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: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• 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: 12/15/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female