THE CUSTOMER SENT PRODUCT SAMPLES. WE WERE UNABLE TO CONFIRM THE COMPLAINT. HENCE LABORATORY TESTING WAS PERFORMED ON SOME OF THE RETURNED SAMPLES OF THIS LOT, AND CONTROL SAMPLES (FROM STOCK) OF ADDITIONAL LOTS OF UNI-SOLVE WIPES WERE ANALYZED BY AN INDEPENDENT TEST LABORATORY AND MET FINISHED PRODUCT SPECIFICATIONS WITH NO EVIDENCE OF MICROBIAL CONTAMINATION FOUND. BATCH RECORDS FOR THE LOTS INDICATE ALL SPECIFICATIONS WERE MET AT THE TIME OF RELEASE AND NO INCONSISTENCIES WERE NOTED. AN INDEPENDENT MEDICAL REVIEW OF THIS COMPLAINT THIS PRODUCT HAS CONCLUDED THAT THERE WAS NO CORRELATION BETWEEN THE REPORTED SYMPTOMS AND THE USE OF THE S&N WIPES.
N
Patient 1
ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION WILL BE PROVIDED IN SUPPLEMENT REPORT. (B)(4).
D
Patient 1
THIS UNISOLVED 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). PATIENT STATES SHE WAS RELEASED FROM THE HOSPITAL (B)(6) 2011. PATIENT ADMITTED ON (B)(6) 2011. PATIENT STATES SHE NOTICED HER SKIN WAS BLACK AND BLUE. PATIENT CALLED HER PHYSICIAN AND WAS TOLD TO GO TO THE HOSPITAL. PATIENT STATES HER BLOOD PLATELETS WERE DOWN. PLATLET NUMBER 100. PATIENT STATES NORMAL PLATLET NUMBER SHOULD BE 40,000. PATIENT STATES SHE RECEIVED AN INFUSION DURING HER HOSPITAL STAY. EMERGENCY ROOM PHYSICIAN STATED PATIENT WAS DIAGNOSED AS HAVING A BACTERIAL INFECTION