UNKNOWN TEDS

Additional Manufacturer Narrative

SUBMIT DATE: (B)(6) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH AN UNKNOWN TED STOCKING. THE CUSTOMER STATES THAT THE PATIENT DEVELOPED AN INGROWN TOENAIL AND INFECTION TO THE LEFT BIG TOE AFTER WEARING THE COMPRESSION STOCKINGS POST LUMBER SURGERY. NO ADDITIONAL INFORMATION PROVIDED RELATED TO TREATMENT.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

THIS COMPLAINT HAS NOT BEEN CONFIRMED. THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW. THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS NOT PROVIDED. WITHOUT THE LOT NUMBER, A DHR REVIEW COULD NOT BE PERFORMED. ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. WITHOUT THE SAMPLE AND LOT NUMBER, IT IS NOT POSSIBLE TO DETERMINE A CONFIRMED ROOT CAUSE OF THIS ISSUE. SHOULD THE SAMPLE BE RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. A CAPA IS NOT DEEMED NECESSARY AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.