T.E.D.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT PERONEAL NERVE PALSY OCCURRED DURING USE OF TED SURGICAL STOCKINGS. TED WAS PUT ON THE PATIENT FOR TOTAL KNEE ARTHROPLASTY. LATER, THE PATIENT COMPLAINED OF NUMBNESS, AND THE PHYSICIAN WHO SAW THE PATIENT DIAGNOSED THEM AS HAVING PERONEAL NERVE PALSY. ADDITIONAL INFORMATION RECEIVED ON 02OCT2023 STATED THAT THE PATIENT HAS DROP FOOT AND POOR DORSIFLEXION DUE TO THIS INCIDENT. THE PATIENT IS CURRENTLY TAKING PHYSICAL THERAPY. THE NUMBNESS HAS DECREASED NOW. IT IS UNKNOWN HOW LONG THE NUMBNESS STAYED. NO OTHER SYMPTOMS WERE EXPERIENCED.

Additional Manufacturer Narrative

A SAMPLE WAS NOT RECEIVED FOR THE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED ISSUE AND DETERMINE THE ROOT CAUSE, THEREFORE A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. IF A SAMPLE IS RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

Additional Manufacturer Narrative

**UDI RELATED DATA QUALITY UPDATES ONLY** CORRECTED SECTION D1 BRAND NAME; CORRECTED SECTION D3 MANUFACTURER NAME; CORRECTED SECTION D4 CATALOG NUMBER; CORRECTED SECTION G4 PMA/510(K)NUMBER; CORRECTED SECTION H5 LABELED FOR SINGLE USE?.