3728LF TED STKG NYL T/L LR

Description of Event or Problem

IT WAS TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A TED STOCKING. THE CUSTOMER REPORTED ON THE (B)(6) 2015, A FEMALE PATIENT HAD A BREAST VASECTOMY AND DIEP AT (B)(6). THE PATIENT HAD TO WEAR THE ANTI-EMBOLISM STOCKINGS AS IT IS STANDARD PROTOCOL AT THE FACILITY. DURING THE DAY OF THE SURGICAL PROCEDURE AND THE NEXT, THE PATIENT REMAINED AT THE FACILITY UNDER A PAIN REGIME. THE PATIENT INDICATED DURING RECOVERY AND WHILE AWAKE, SHE DID NOT FEEL PAIN IN HER BREAST OR STOMACH, BUT PAIN ON HER LEGS WHERE THE T.E.D. STOCKINGS WERE. ONCE THE STOCKINGS WERE REMOVED, THERE WERE 6 BLISTERS 3 X 3 CENTIMETERS IN SIZE LOCATED UNDER THE TOP BAND OF THE T.E.D. STOCKING. IT WAS ALSO REPORTED THE RECOVERY OF THE ORIGINAL SURGICAL PROCEDURE IS GOING SMOOTHLY, BUT THE PATIENT HAD TO STAY IN AN EXTRA DAY AT HOSPITAL AND IS STILL ON HEAVY PAIN REGIME FOR THE BLISTERS.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION AND CONSISTED OF TWO T.E.D ANTI-EMBOLISM ELASTIC STOCKINGS, THIGH LENGTH, LARGE REGULAR, WHITE, NONSTERILE. THE STOCKINGS DID NOT PRESENT SIGNS OF USE. THE LOT NUMBER RECEIVED ON THE SAMPLE WAS 1431900227. THE DEVICE HISTORY RECORD WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARD REQUIREMENTS. THERE WERE NO NON-CONFORMING ISSUES REPORTED DURING THE PRODUCTION OF THIS PRODUCT FOR A SIMILAR CONDITION AS REPORTED IN THIS COMPLAINT. PHOTOS WERE ALSO RECEIVED FOR EVALUATION. BLISTERS WERE OBSERVED ON THE UPPER AREA OF THE PATIENT¿S LEG. POSSIBLE ROOT CAUSES COULD BE DUE TO IMPROPER SIZING, THE STOCKING MAY HAVE BEEN SMALLER THAN THE REQUIRED SIZE OR DUE TO IMPROPER APPLICATION OF THE STOCKING. CONTROLS, SUCH AS IN-PROCESS VISUAL INSPECTION, VOLUME TESTING AND COMPRESSION TESTING, ARE IN PLACE TO PREVENT NON-CONFORMING MATERIAL FROM LEAVING THE MANUFACTURING PROCESS. ACCORDING TO THE PROCESS SPECIFICATION TED STOCKINGS PACKAGING, ALL THE STOCKING PACKAGES INCLUDE THE INSERT DOCUMENT WITH THE INSTRUCTIONS FOR APPROPRIATE STOCKINGS APPLICATION AND USE. THE TED STOCKINGS PRODUCTS WERE SUBMITTED TO CYTOTOXICITY TESTING AND SKIN IRRITATION EVALUATION, MEETING THE REQUIREMENTS FOR INTENDED USE. A CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (PERSONNEL TRAINING, IN-PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATION.