THIS SKIN PREP COMPLAINT WAS RECEIVED POST SMITH & NEPHEW'S REMEDIAL ACTION (VOLUNTARY RECALL) TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH (REF. RECALL #3006760724-04-06-2011-001R). THE LOT OF PRODUCT ASSOCIATED WITH THIS EVENT WAS NOT SUBJECTIVE TO THE RECALL NOTED. ADVERSE INCIDENT REPLACED INSULIN PUMP SITE, (B)(6) WHEN REPLACING PATIENT NOTICED A SMALL POINT OF IRRITATION, (SMALL AS A BALLPOINT PEN.) PROGRESSIVELY BECAME WORSE AS TIME WENT ON. WENT TO VISIT THE DOCTOR TO HAVE THE INFLAMED AREA CHECKED OUT, AND THEN SENT TO THE HOSPITAL; MORE SPECIFICALLY TO THE EMERGENCY ROOM TO HAVE IT CHECKED OUT. DOCTORS AT THE EMERGENCY ROOM IMMEDIATELY PLANNED FOR SURGERY THE FOLLOWING DAY (B)(6). THE PORTION THAT WAS SWOLLEN HAD BECOME 21 BY 9 CM LARGE. WHEN SURGERY TOOK PLACE, IT CONTINUED TO GROW BY 25 BY 12 CM.
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Patient 1
THE SAMPLES WERE RETURNED BY THE CUSTOMER. THE SAMPLES WERE NOT TESTED BY THE OUTSIDE LAB OR BY S&N SINCE THIS LOT WAS MANUFACTURED BY S&N PRIOR TO SHUT DOWN, AND THEREFORE WERE NOT SUBJECTED TO THE RECALL. BASED ON A HISTORICAL REVIEW OF THIS PRODUCT TESTING OF SAMPLES IS NOT WARRANTED AT THIS TIME . THE BATCH RECORD RELATED TO THIS LOT 522186 WAS REVIEWED AND CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS AND MET ALL THE RELEASE CRITERIA. THE PRODUCT WAS MANUFACTURED AND RELEASED IN MARCH 2009. THE PRODUCTION ENVIRONMENT WAS CONTROLLED TO (B)(4) ADEQUATE ENVIRONMENTAL MONITORING WAS PERFORMED TO ENSURE THAT PRODUCT IS MANUFACTURED UNDER CLEAN ENVIRONMENT. (B)(4). THERE WERE NO ISSUES REPORTED WITH THIS LOT SINCE IT WAS DISTRIBUTED. THIS IS THE ONLY COMPLAINT REPORTED FOR THIS LOT. THERE WERE NO RECALLS ISSUED BY S&N FOR THIS PRODUCT PRIOR TO THE RECALL IN 2011. OUR MEDICAL AND CLINICAL REVIEWS OF SIMILAR COMPLAINTS ASSOCIATED WITH THIS PRODUCT HAVE CONCLUDED THAT S&N PRODUCT ARE NOT THE ROOT CAUSE OF THIS ISSUE. MICROBIAL TESTING HAS BEEN ADDED FOR THIS PRODUCT PRIOR TO RELEASE.