| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SKIN PREP WIPES | BANDAGE, LIQUID, SKIN PROTECTANT | SMITH & NEPHEW WOUND MANAGEMENT | NEC | 420400 | UNKNOWN | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-10-25 | 0 | 1. H |
Patient 1
PATIENT'S WIFE STATES, HER HUSBAND HAS BEEN IN AND OUT OF THE HOSPITAL SEVERAL TIMES SINCE(B)(6) 2011. PATIENT DIAGNOSED WITH HAVING AN UNKNOWN BACTERIAL INFECTION. PATIENT'S WIFE STATES, HER HUSBAND WOULD TAKE HIS PRESCRIBED ANTIBIOTICS AND HIS SYMPTOMS WOULD GET BETTER WHILE TAKING HIS MEDICATION.
Patient 1
SMITH & NEPHEW WAS CONTACTED REGARDING THE ABOVE DESCRIBED INCIDENT, WHICH WAS REPORTED AS A FIELD COMPLAINT FOR "ADVERSE INCIDENT". THERE WERE NO SAMPLES RETURNED BY THE CUSTOMER AND SO COMPLAINT CANNOT BE CONFIRMED. THERE WAS NO LOT NUMBER PROVIDED AND SO THE MANUFACTURING LOCATION OF THE PRODUCT IS NOT KNOWN. S&N HAS MANUFACTURED THIS PRODUCT AT 3 DIFFERENT LOCATIONS IN THE LAST 3 YEARS. SOME RETAIN SAMPLES OF SKIN PREP WIPES LOTS MANUFACTURED BY THIS SUPPLIER WERE TESTED BY AN INDEPENDENT TEST LABORATORY AND MET FINISHED PRODUCT SPECIFICATIONS WITH NO EVIDENCE OF MICROBIAL CONTAMINATION FOUND. BATCH RECORDS COULD NOT BE REVIEWED FOR THE LOT. SKIN PREP IS DESIGNED TO BE USED TO REDUCE RISK OF IRRITATION DUE TO FRICTION. IT IS VERY CRITICAL THAT THE SOLVENT IS ALLOWED TO DRY COMPLETELY BEFORE ANY DEVICE IS APPLIED. SOMETIMES SKIN IRRITATION UNDER NORMAL USE IS EXPECTED TO OCCUR AND SEVERITY IS LOW- NON-SERIOUS INJURY AND SIGNIFICANT DISCOMFORT. ADDITIONALLY, IF SUFFICIENT PRODUCT IS NOT APPLIED, IT CAN LEAD TO INFECTION SINCE THE DEVICE IS NOT SECURELY ATTACHED. MEDICAL REVIEW OF THIS COMPLAINT WITH THIS PRODUCT CONFIRMED THAT THE REPORTED SYMPTOMS CANNOT BE ATTRIBUTED TO THE USE OF S&N WIPES PRODUCT. THE ROOT CAUSE OF THE ISSUE IS UNKNOWN.