SURGIMESH WN
Received Sep 9, 2015 · Event occurred Aug 10, 2015
Report 3005841068-2015-00011 · MDR key 5070411
Device
Generic name
T1415-8
Manufacturer
Aspide MedicalModel number
T1415-8Catalog number
T1415-8
Lot number
F08899A
Product problems
- Contamination
Patient
21 YR
- Unspecified Infection
Narrative
Description of Event or Problem
ON (B)(6) 2014 THE PATIENT HAD AN OPEN VENTRAL HERNIA REPAIR USING TWO PIECES OF SURGIMESH WN T1415-8. APPROXIMATELY A MONTH P.O. THE PATIENTS SKIN WOUND FROM THE VENTRAL HERNIA REPAIR BROKE DOWN. ON (B)(6) 2014 THE PATIENTS WOUND WAS IRRIGATED, DEBRIDED AND RE-CLOSED. THE PATIENT WAS GIVEN ANTIBIOTICS ON (B)(6) 2014 THE PATIENTS WOUND WAS AGAIN IRRIGATED, DEBRIDED AND A WOUND VAC PLACED. ON (B)(6) 2015 THE PATIENTS ABDOMINAL WOUND WAS MAKING PROGRESS AND THERE WAS EVIDENCE OF GRANULATION TAKING PLACE. AT A (B)(6) 2015 CHECK-UP THE PATIENTS ABDOMINAL WOUND WAS CONTINUING TO HEAL, A BIT SLOWLY. ON (B)(6) 2015 THE PATIENT WAS BROUGHT TO THE SURGEONS OFFICE FOR EXCISION OF UNINCORPORATED T1415-8, IRRIGATION OF THE SITE AND DEBRIDEMENTS. BY (B)(6) 2015 THE PATIENT CALLED INDICATING THAT DRAINAGE HAD INCREASED. ON (B)(6) 2015 THE SURGEON EXCISED THE REMAINING T1415-8 AND CLOSED THE PATIENTS ABDOMINAL WALL. THE STERILITY AND ACCEPTABILITY FOR CLINICAL USE OF THE SURGIMESH WN T1415-8 WAS CONFIRMED THROUGH THE MANUFACTURER LOT HISTORY RECORDS.