MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC J&J BAND AID BRAND FIRST AID PAPER TAPE; TAPE AND BANDAGE, ADHESIVE

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

Patient Problems Itching Sensation (1943); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age at time of event, weight, and ethnicity and race were not provided for reporting.This report is for one (1) j&j band aid brand first aid paper tape unspecified usa not applicable jjbpptusunsp, jjbpptusunsp.Lot # and udi # are not available.Device is not expected to be returned for manufacturer review/investigation.Device evaluation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A female consumer reported an event with unspecified j& j band aid brand first aid paper tape.The consumer was putting a topical cream on her arm for dermatitis and did not want the cream to absorb into the band-aid.She used paper tape for the dermatitis that first started on the inside of her elbow and now she has ringworm like lesions that are not getting any better.Consumer¿s whole arm feels like it is covered in cigarette burns and has non-stop itching.Her arm feels like it is swollen, painful and tight.Consumer just wanted to claw at her arm, it was so painful and intense.Consumer sought medical attention from a health care professional.Consumer was prescribed steroids as treatment.

• Brand Name: J&J BAND AID BRAND FIRST AID PAPER TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 9744500
• MDR Text Key: 191040686
• Report Number: 2214133-2020-00007
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• 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
• Event Location: Other
• Date Manufacturer Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention