| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNI-SOLVE WIPES | SOLVENT, ADHESIVE TAPE | SMITH & NEPHEW WOUND MANAGEMENT | KOX | 402300 | 402300 | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-07-28 | 0 | 1. D |
Patient 1
THIS (B)(4) COMPLAINT WAS RECEIVED POST SMITH & NEPHEW'S REMEDIAL ACTION (VOLUNTARY RECALL) TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH ((B)(4)). ULCER THINGS APPEARED THEN WENT AWAY AFTER (B)(6) UNDER DOCTORS CARE. PATIENT PLACED ON BAG IN 1998, AND DEVELOPED URINARY TRACT INFECTION, AND SUBSEQUENTLY WENT SEPTIC. PATIENT DIED ON OR AROUND (B)(6) 2010.
Patient 1
ACTIVE INVESTIGATION IS CURRENTLY IN PROGRESS BY SMITH & NEPHEW, AS WELL AS A REVIEW OF THE INCIDENT DETAILS BY OUR MEDICAL ADVISOR. INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENT REPORT ONCE A THOROUGH INVESTIGATION HAS BEEN COMPLETED. (B)(4).
Patient 1
THE CUSTOMER DID NOT RETURN ANY PRODUCT. WE WERE UNABLE TO CONFIRM THE COMPLAINT SINCE THE LOT NUMBER WAS NOT PROVIDED AND NO SAMPLES WERE TESTED. S&N HAS MANUFACTURED THIS PRODUCT AT 2 DIFFERENT LOCATIONS AND SO WITHOUT THE LOT NUMBER, THE PRODUCTION RECORDS CANNOT BE REVIEWED AND FURTHER INVESTIGATION CANNOT BE PERFORMED. CONTROL SAMPLES (FROM RETAINS STOCK) OF SOME LOT OF UNI-SOLVE WIPES MANUFACTURED BY TRIAD WERE ANALYZED BY AN INDEPENDENT TEST LABORATORY AND MET FINISHED PRODUCT SPECIFICATIONS WITH NO EVIDENCE OF MICROBIAL CONTAMINATION FOUND. AN INDEPENDENT MEDICAL REVIEW OF THIS EVENT INDICATED THAT THERE IS NO MEDICAL EVIDENCE TO SUPPORT ANY RELATIONSHIP BETWEEN THE USE OF UNISOLVE WIPES, AND THE PATIENT'S SYMPTOMS AND/OR SUBSEQUENT DEATH.