THIS UNISOLVE 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). ADVERSE INCIDENT PATIENT WENT TO THE EMERGENCY ROOM (B)(6)-2011 DUE TO PAIN IN HIS STOMACH. PATIENT WENT TO HIS PHYSICIAN AND WAS TOLD TO GO TO THE EMERGENCY ROOM. PER ER PHYSICIAN: PATIENT WAS DIAGNOSED WITH HAVING A BACTERIAL INFECTION. EMERGENCY ROOM PHYSICIAN ORDERED CT SCAN. CT SCAN RESULTS: INFLAMMATION BEHIND THE STOMA. PATIENT WAS GIVEN AN ANTIBIOTIC.
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Patient 1
SMITH & NEPHEW WAS CONTACTED REGARDING THE ABOVE DESCRIBED INCIDENT, WHICH WAS REPORTED AS A FIELD COMPLAINT FOR "INFECTION-SITE/LOCAL". THE CUSTOMER SENT IN SOME PRODUCT SAMPLES. WE WERE UNABLE TO CONFIRM THE COMPLAINT BASED ON INSPECTION OF THE RETURNED SAMPLES, HENCE LABORATORY TESTING WAS PERFORMED. BOTH THE RETURNED SAMPLE(S) AND CONTROL SAMPLES (FROM STOCK) OF LOT 0K208 WERE ANALYZED BY AN INDEPENDENT TEST LABORATORY AND MET FINISHED PRODUCT SPECIFICATIONS WITH NO EVIDENCE OF MICROBIAL CONTAMINATION FOUND. BATCH RECORDS FOR THE LOT INDICATE ALL SPECIFICATIONS WERE MET AT THE TIME OF RELEASE AND NO INCONSISTENCIES WERE NOTED. AN INDEPENDENT MEDICAL REVIEW CONCLUDED THERE WAS NO CORRELATION BETWEEN THE REPORTED SYMPTOMS AND THE USE OF UNI-SOLVE WIPES. (B)(4)