CVS AB FT/KN BNDG 20CT
Received May 17, 2023 · Event occurred Jan 27, 2023
Report 3007187674-2023-00001 · MDR key 16948198
Device
Generic name
Wound Dressing
Manufacturer
Planet (anhui) Medical Products Co., LtdModel number
875952Lot number
22CJ01
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Contact Dermatitis
- Contact Dermatitis
Narrative
Description of Event or Problem
USER DEVELOPED MASSIVE ALLERGIC DERMATITIS FROM THE FLEXIBLE FABRIC BANDAIDS. USER RECEIVED A SIMILAR REACTION FROM THE SPORT BANDAIDS, BUT NEVER BEFORE HAS IT BEEN THIS SEVERE. USER PROVIDED IMAGE OF PROGRESSION OF REACTION FROM FRIDAY TO MONDAY. THE BANDAGES WERE COVERING A FUNGAL INFECTION, WHICH HAS SINCE CLEARED UP, BUT THE AREA SURROUNDING HAS GOTTEN WORSE. USER REPORTED GOING TO THE ER TWICE FOR BOILS ON HER NECK. ADDITIONAL INFORMATION OBTAINED: USER FOLLOWED UP WITH PCP, NOTED THAT RX WAS PRESCRIBED.
Additional Manufacturer Narrative
PLEASE SEE THE ATTACHMENT FILE FOR TEST REPORT. THE RAW MATERIALS AND PRODUCTION PROCESS OF THE PRODUCT HAVE RAMAINED THE SAME. WE TESTED THE RESERVED SAMPLES ON 20 VOLUNTEERS FOR 24 HOURS UPON KNOWING THE CASE, AND NONE OF THE 20 PEOPLE SHOWED ALLERGIC SYMPTOMS. WE BELIEVE THIS ALLERGY WAS ACCIDENTAL.
Remedial action
- Inspection