PREMIER FLEXTEND BARRIER WITH TAPE AND LOCK N ROLL CLOSURE

Additional Manufacturer Narrative

THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THERE IS NO TREND OBSERVED FOR THIS SKU AND COMPLAINT TYPE.

Description of Event or Problem

IT WAS REPORTED THAT THE END USER DEVELOPED IRRITATION ON (B)(6) 2018. THE AREA IS RED, IRRITATED AND BLEEDS EASILY. ON (B)(6) 2018 SHE SOUGHT MEDICAL TREATMENT AND WAS PRESCRIBED ORAL ANTIBIOTICS AND CLOTRIMAZOLE AND BETHAMETHAZONE DITROPIONATE. SHE IS BEGINNING TO SEE A LITTLE IMPROVEMENT.