DIV 34 REHAB & FALL PREVENTION

Additional Manufacturer Narrative

UPDATE TO D2: COMMON DEVICE NAME. UPDATE TO D4: CATALOG #.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 AN "ACCU-THERM" PACK WAS USED ON THE RIGHT ANTECUBITAL FOSSA AFTER BLOOD DONATION DUE TO SWELLING. THE CUSTOMER STATED THAT THE DEVICE WAS WRAPPED IN A "KITCHEN TOWEL" AND PLACED ON THE AREA FOR APPROXIMATELY "20 MINUTES" WHEN A "BURNING" SENSATION WAS FELT. THE CUSTOMER SAID THAT THE GEL HAD "OOZED OUT" OF THE "BACK SEAM" OF THE PACK, SEEPED THROUGH THE TOWEL, AND MADE CONTACT WITH THEIR SKIN.

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 AN "ACCU-THERM" PACK WAS USED ON THE RIGHT ANTECUBITAL FOSSA AFTER BLOOD DONATION DUE TO SWELLING. THE CUSTOMER STATED THAT THE DEVICE WAS WRAPPED IN A "KITCHEN TOWEL" AND PLACED ON THE AREA FOR APPROXIMATELY "20 MINUTES" WHEN A "BURNING" SENSATION WAS FELT. THE CUSTOMER SAID THAT THE GEL HAD "OOZED OUT" OF THE "BACK SEAM" OF THE PACK, SEEPED THROUGH THE TOWEL, AND MADE CONTACT WITH THEIR SKIN. THE CUSTOMER SAID THAT A "RED MARK" AND SWELLING DEVELOPED ON THE AREA THAT LED TO "BLISTERED, SCALEY, AND BRUISED" SKIN. THE CUSTOMER STATED THAT THEY ARE USING "A&D" CREAM ON THE AFFECTED AREA AND WRAPPING THE ARM WITH GAUZE. THE CUSTOMER SAID THEY SAW THE DOCTOR ON (B)(6) 2025 AND THE DOCTOR SUSPECTS "MUSCLE DAMAGE" FROM A CHEMICAL OR FROSTBITE AND THAT THERE WILL BE "SCARRING." THE CUSTOMER REPORTED THAT SHE WAS PRESCRIBED BACLOFEN AND PHYSICAL THERAPY BUT DECLINED BOTH. THE CUSTOMER SAID THAT SHE HAS PAIN WHEN "EXTENDING" HER ARM AND CONTINUED "SWELLING" AND "BLISTERS." IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.