MAUDE Adverse Event Report: JOHNSON AND JOHNSON CONSUMER INC. JOHNSON AND JOHNSON ADHESIVE BANDAIDS; BANDAGE, ELASTIC

Lot Number 211105

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 11/29/2022

Event Type  malfunction  

Event Description

I placed a bandaid on and got a rash in the shape of the bandaid.It itches like crazy! johnson and johnson band aid adhesive bandages 211105 made in brazil.I have never had problems with band aids before and i am 44 years old.Bleeding injury small.

• Brand Name: JOHNSON AND JOHNSON ADHESIVE BANDAIDS
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): JOHNSON AND JOHNSON CONSUMER INC.
• MDR Report Key: 15906191
• MDR Text Key: 304867565
• Report Number: MW5113585
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 211105
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White