STRAPS: DISPOSABLE FOAM KNEE / BODY STRAP, 4" X 60"

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE FACILITY WAS PERFORMING A PROCEDURE ON A PATIENT AND WHILE THE PATIENT WAS STRAPPED WITH THE BODY STRAP AND LEANED TO THE SIDE THE STAFF REPORTED THAT THE HOOK AND LOOP BECAME DISENGAGED AND THE PATIENT FELL TO THE GROUND RESULTING IN A FRACTURE TO AN UNSPECIFIED LOCATION OF THE PATIENT'S SKULL. DUE DILIGENCE HAS BEEN COMPLETED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. DUE TO THE REPORTED INCIDENT, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

THE FACILITY REPORTED THAT THE LOOP AND HOOK FROM THE POSITIONING STRAP FAILED DURING A PROCEDURE CAUSING A PATIENT TO FALL OFF THE TABLE AND FRACTURE HER SKULL.