MAUDE Adverse Event Report: WELLY HEALTH PBC WELLY BRAND FABRIC BANDAGE; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Tears (2516)

Event Date 06/07/2022

Event Type  Injury  

Event Description

Three-yr old removed welly brand bandage and the adhesive part actually pulled off skin.Bandage info: ice cream design, purchased at target, no other mfg codes on the storage tin, i think the codes must only be on the outer sleeve that is thrown away.(b)(6) target on (b)(6).Fda safety report id# (b)(4).

• Brand Name: WELLY BRAND FABRIC BANDAGE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WELLY HEALTH PBC
• MDR Report Key: 14653783
• MDR Text Key: 293880095
• Report Number: MW5110236
• 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: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/07/2022

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 14 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White