MAUDE Adverse Event Report: 3M COMPANY NEXCARE MAX HOLD WATERPROOF BANDAGES; TAPE AND BANDAGE, ADHESIVE

Lot Number 21300M 00153230

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

Patient Problems Scar Tissue (2060); Blister (4537)

Event Date 02/17/2022

Event Type  Injury  

Event Description

Skin blistering and scaring; severe skin reaction when using nexcare max hold 60 count one size bandages.I have used this product for a number of years and this is new boxed received is the first time that i had a reaction to the product.Product details and skin reaction pictures provided below.Fda safety report id # (b)(4).

Event Description

Skin blistering and scaring; severe skin reaction when using nexcare max hold 60 count one size bandages.I have used this product for a number of years and this is new boxed received is the first time that i had a reaction to the product.Product details and skin reaction pictures provided below.Fda safety report id # (b)(4).

• Brand Name: NEXCARE MAX HOLD WATERPROOF BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 13592308
• MDR Text Key: 286164008
• Report Number: MW5107677
• 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
• Type of Report: Initial
• Report Date: 02/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 21300M 00153230
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White