inforMED
InjuryOXJ

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 Medical

Model number

T1415-8

Catalog 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.