PREVALON TAP 2.0 MULTIPK 3

Description of Event or Problem

REPORT RECEIVED OF A SERIOUS INJURY INVOLVING A USER. IT WAS REPORTED THAT, IN NOVEMBER 2025 (EXACT EVENT DATE UNKNOWN), A FEMALE CLINICIAN SUSTAINED AN INJURY TO THE WRIST/HAND WHILE USING THE 7206 TAP 2.0 SYSTEM. THE CLINICIAN WAS WORKING WITH ANOTHER HEALTHCARE WORKER TO REPOSITION A PATIENT WITH A LARGER BODY SIZE. AFTER THE LOWER WEDGE HAD BEEN PLACED BENEATH THE PATIENT'S THIGHS, THE CLINICIAN REACHED UNDERNEATH THE PATIENT'S LOWER BODY IN AN ATTEMPT TO MANUALLY PULL THE ANCHOR WEDGE TAIL THROUGH AND MAKE IT TAUT. IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN ROLLED ONTO THEIR SIDE TO FACILITATE ACCESS TO THE WEDGE. WHILE ATTEMPTING TO PULL THE ANCHOR WEDGE TAIL, BOTH CAREGIVERS EXPERIENCED DIFFICULTY, AND THE CLINICIAN IMMEDIATELY FELT PAIN IN THE WRIST/HAND AREA. INITIAL IMAGING REPORTEDLY SHOWED NO ABNORMALITIES. APPROXIMATELY ONE MONTH LATER, MRI IMAGING IDENTIFIED A HAIRLINE FRACTURE OF THE DISTAL ULNA AND A LIGAMENT TEAR. THE CLINICIAN WAS SUBSEQUENTLY TREATED WITH A CAST. THERE WAS NO REPORT OF SURGICAL INTERVENTION. FOLLOWING THE INJURY, THE CLINICIAN EXPERIENCED ONGOING SWELLING AND CHRONIC PAIN AND HAS REMAINED OFF WORK AND ON WORKERS' COMPENSATION SINCE THE INCIDENT. THE REPORTER STATED THAT THE TAP 2.0 SYSTEM OPERATED AS INTENDED AND THAT NO PRODUCT MALFUNCTION WAS IDENTIFIED. THE LOT NUMBER IS UNKNOWN, AND THE PRODUCT IS NOT AVAILABLE FOR EVALUATION BECAUSE IT WAS DISCARDED. NO ADDITIONAL INFORMATION REGARDING THE CLINICIAN'S CURRENT CONDITION WAS PROVIDED.