MEDLINE

Description of Event or Problem

ACCORDING TO THE CUSTOMER CONTACT, "EARLY 2026-ONGOING", "PATIENTS EXPERIENCE SIGNIFICANT DERMATOLOGIC REACTIONS ASSOCIATED WITH THE BORDERED GAUZE INCLUDED IN OUR CUSTOM PACKS."

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER CONTACT, "EARLY 2026-ONGOING", "PATIENTS EXPERIENCE SIGNIFICANT DERMATOLOGIC REACTIONS ASSOCIATED WITH THE BORDERED GAUZE INCLUDED IN OUR CUSTOM PACKS." THE CUSTOMER CONTACT REPORTED, "OUR STANDARD POSTOPERATIVE PROCESS IS TO APPLY STERI-STRIPS FOLLOWED BY THE BORDERED GAUZE, AND PATIENTS ARE RETURNING WITH CONCERNING SYMPTOMS SUCH AS RASH, BLISTERING, PRURITUS, AND ASSOCIATED DISCOMFORT." THE CUSTOMER CONTACT REPORTED THIS HAS HAPPENED TO "MULTIPLE PATIENTS". THE CUSTOMER CONTACT REPORTED "DRESSING CHANGE" AND "F/UP CARE TO ADDRESS THE DERMAL SIDE EFFECTS AND TO PREVENT SCARRING" HAD BEEN REQUIRED. FOLLOWING THE REPORTED INCIDENT, THE CUSTOMER CONTACT NOTED THERE WAS "IMPROVEMENT TO DERMIS WITH REMOVAL OF BORDERED GAUZE" AND STATED, "WILL CONTINUE TO MONITOR FOR LONG TERM EFFECTS." PER THE CUSTOMER CONTACT, "FOR PATIENT SAFETY AND QUALITY-OF-CARE REASONS, WE ARE LOOKING TO MAKE ADJUSTMENTS TO OUR POSTOPERATIVE DRESSINGS TO HELP PREVENT THESE REACTIONS." NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE CUSTOMER REPORTED INCIDENT. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.