TRACTION SET CERVICAL OVERDOOR

Additional Manufacturer Narrative

THE DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDER EVALUATION. THE DEVICE EVALUATION AND ANY ADDITIONAL FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVALUATION.

Description of Event or Problem

THE PATIENT WAS PRESCRIBED THE USE OF THE OVER THE DOOR TRACTION KIT BY HER PHYSICAL THERAPIST. THE KIT WAS PURCHASED. THE PATIENT TOOK THE KIT INTO HER PHYSICAL THERAPIST AND THEY DISCUSSED HOW THE KIT SHOULD BE USED. AT HOME, SHE AND HER SPOUSE SET UP THE TRACTION KIT AND PER INSTRUCTIONS FROM HER PHYSICAL THERAPIST ADDED 10 POUNDS OF WATER TO THE BAG. THE PATIENT FOLLOWED INSTRUCTION PLACING HER CHIN INTO THE CHIN STRAP AND PLACE THE SECOND STRAP AROUND THE BACK OF HER HEAD ACCORDING TO INSTRUCTIONS. THE PATIENT HAS WORKED IN THE MEDICAL PROFESSION AND INDICATED THAT SHE KNEW WHEN TO STOP. THE TREATMENT WAS PAINFUL AND SEEMED TO HER THAT IT WAS PULLING TOO MUCH ON THE CHIN. AFTER ABOUT TWO MINUTES, THE PATIENT STOPPED USING THE DEVICE DUE TO INTENSE PAIN. HER PHYSICAL THERAPIST SUGGESTED THAT SHE TRY THE DEVICE A SECOND TIME AND THE SAME PROBLEM OCCURRED, JAW AND NECK PAIN. THE PATIENT FEELS THAT THE DESIGN OF THE DEVICE PULLS UP TOO MUCH ON THE CHIN AND IF THE HEAD IS HELD WITH THE EYES STRAIGHT FORWARD THE CHIN STRAP CUTS INTO THE NECK. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE PATIENT DID NOT FEEL THAT ANY INJURY OCCURRED OR THAT HER PROGRESS WAS IMPEDED. SHE STRONGLY FELT THAT THE PRODUCT JUST DOES NOT WORK PROPERLY AND THAT THE MANUFACTURER SHOULD KNOW.