MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC. BAND-AID BRAND ADHESIVE BANDAGE; TAPE AND BANDAGE, ADHESIVE

Model Number 211109

Device Problems Material Disintegration (1177); Physical Resistance/Sticking (4012)

Patient Problems Pain (1994); Skin Irritation (2076)

Event Date 12/18/2020

Event Type  Injury  

Event Description

Pain and skin reaction; on friday, (b)(6) 2020, i accidentally pulled off a small piece of the skin on my r hand about an inch below the knuckle of my index finger while trying to adjust a bolster on my sofa.I cleaned it with soap and water and applied pressure with a gauze pad before putting a j&j band-aid over the cut vertically from my knuckle to almost my wrist.I left it on until sunday morning when i attempted to remove it.Regardless of how i pulled at it, it would not come off.I felt like it was cemented on or at least super-glued.After a few minutes of picking off very tiny fragments from the top edge, i decided to soak the hand in warm water for 5 minutes to loosen the adhesive.It kept coming off in very tiny pieces until after another 5 minutes or so, i got to the bandage portion over the cut.I knew i had to pull downward to keep the skin in place that had ripped upward.I am enclosing the files showing my receipt for buying the box of band-aids at (b)(6), a picture of the band-aid in its wrapper, a picture out of the wrapper, and two pictures of how my hand looked after removing the bandage at 9:09 a.M.And at 6:45 p.M on (b)(6).Is this product defective and subject to recall? i have never had one of your products become impossible to remove nor have i had my skin look as it does in the photos after removing a band-aid.Please advise how you intend to remedy this problem.Fda safety report id # (b)(4).

• Brand Name: BAND-AID BRAND ADHESIVE BANDAGE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.
• MDR Report Key: 11100465
• MDR Text Key: 224855571
• Report Number: MW5098598
• Device Sequence Number: 1
• Product Code: KGX
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 211109
• Device Catalogue Number: 1367085 (COSTCO)
• Device Lot Number: N/K
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 82