FDA Adverse Event Injury Summary report: N

BAND-AID

MDR report key: 17409541 · Received July 26, 2023

Report

Report Number
MW5120206
Event Type
Injury
Date Received
July 26, 2023
Date of Event
July 8, 2023
Report Date
July 17, 2023
Manufacturer
JOHNSON & JOHNSON CONSUMER INC.
Product Code
KGX
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD AN ALLERGIC REACTION TO THE ADHESIVE ON "FLEXIBLE FABRIC" "BAND-AID" BRAND ADHESIVE BANDAGES. UPC CODE 3 8137-115078 6. LOT2L0608 0622. MY SKIN AREA UNDER THE ADHESIVE PARTS BECAME RED, INFLAMED, RASH, THE ENTIRE WOUND AREA BECAME REDDER, AND SWOLLEN. THE ORIGINAL WOUND WAS AN ABRASION AND SCRATCH, SOME BLOOD, BUT NOT BLEEDING, SHIN OF LEFT LEG. I WASHED IT, APPLIED BACITRACIN ZINC OINTMENT, AND COVERED IT WITH A LARGE BAND-AID, USED NEW BAND-AID TWICE A DAY, THEN ONCE PER DAY. AS WOUND AREA BECAME REDDER AND MORE ITCHY, I THOUGHT THERE WAS AN INFECTION. I WAS MORE DILIGENT AT REPLACEMENT. ON (B)(6), I CONTACTED THE (B)(6) CENTER (B)(6) AND SENT A PICTURE OF THE WOUND. THEY ADVISED ME TO UNCOVER THE WOUND AND STOP USING THE BAND-AID AND OINTMENT. ON FRIDAY, (B)(6) 2023, I VISITED THE OUTPATIENT CLINIC. I WAS TOLD WHAT HAPPENED WAS LIKELY AN ALLERGIC REACTION TO THE ADHESIVE ON THE BAND-AIDS. OVER THE WEEKEND, THE REDDENED AREAS CLEARLY SHOWED THE PATTERN OF THE BAND-AID WINGS. ON MONDAY (B)(6), 2023, THE RASH IS STILL PRESENT, BUT IMPROVING. I PLAN TO CALL JOHNSON & JOHNSON ON READING SOME WEB PAGES, THERE WAS AN INDICATION THAT ADHESIVE ALLERGY IS UNCOMMON. HOWEVER, WHEN I MENTIONED IT TO A FRIEND, SHE SAID HER PARTNER HAD A BAD ADHESIVE REACTION. THE NURSE AT THE VA SAID SHE HAD A REACTION TO A BANDAID. I THINK THIS MAY BE COMMON, NOT UNCOMMON, AND POSSIBLY UNDER-REPORTED. THAT IS WHY I AM FILING THIS REPORT. REFER TO ADDITIONAL DOCUMENTS IN 12K.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1467346 BAND-AID TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC. FLEXIBLE FABRIC 210608

Patients

Seq Age Sex Outcome Treatment
1 66 YR Male Required Intervention ALIGN PROBIOTIC.| ATORVASTATIN 40MG.| LEVOTHYROXINE 25 MCG.