MAUDE Adverse Event Report: WELLY HEALTH PBC FLEX FABRIC BANDAGE; ADHESIVE BANDAGES

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

Patient Problems Pain (1994); Skin Tears (2516); Skin Infection (4544)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

Welly health pbc is filling this form for transparency and acknowledgement of the complaint.This report and the information submitted as part of this report do not constitute an admission that the device or welly health pbc or any of its employees caused or contributed to the event described herein or that the event as reported to welly health pbc occurred.

Event Description

On 28-dec-2023, a spontaneous report was received from the united states regarding a female (age not provided) consumer who used a welly health flex fabric bandage.On an unspecified date, the consumer applied a flex fabric bandage topically to her knee for an unspecified indication.Approximately on (b)(6) 2023, while taking off the bandage, her skin was ripped.She gave the area proper attention.On b)(6) 2024, her knee started hurting.By b)(6) 2023, she went to urgent care due to her knee and learned she had developed a staph infection.The infection had settled in her knee which she had surgery to remove the infection.No additional information was provided.

Event Description

On 28-dec-2023, a spontaneous report was received from the united states regarding a female (age not provided) consumer who used a welly health flex fabric bandage on an unspecified location on approximately (b)(6) 2023.While removing the bandage, her skin was ripped.The report stated that she gave the area proper attention.On (b)(6) 2024, her knee started hurting (pictures associated with report depict usage of the flex fabric bandage on a location that appears not associated with the knee).By (b)(6) 2023, she went to urgent care where she learned that she had developed a staph infection.The infection had settled in her knee and she had surgery to remove the infection.No additional information was provided.

Manufacturer Narrative

Welly health pbc is filling this form for transparency and acknowledgement of the complaint.This report and the information submitted as part of this report do not constitute an admission that the device or welly health pbc or any of its employees caused or contributed to the event described herein or that the event as reported to welly health pbc occurred.

• Brand Name: FLEX FABRIC BANDAGE
• Type of Device: ADHESIVE BANDAGES
• 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: 18547797
• MDR Text Key: 333315579
• Report Number: 3016050930-2023-00006
• 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,Followup
• Report Date: 01/17/2024

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: 12/28/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 01/19/2024
• 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