BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7475274 · Received May 1, 2018

    Report

    Report Number
    2210968-2018-72479
    Event Type
    Injury
    Date Received
    May 1, 2018
    Report Date
    March 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: HERNIA. 2015; 19: 267 271. DOI: 10.1007/S10029-014-1262-4. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: A COMPARATIVE STUDY OF SUTURED VERSUS BOVINE PERICARDIUM MESH ABDOMINAL CLOSURE AFTER OPEN ABDOMINAL AORTIC ANEURYSM REPAIR" AUTHORS: C. BALI, J. PAPAKOSTAS, G. GEORGIOU, G. KOUVELOS, S. AVGOS, E. ARNAOUTOGLOU, G. PAPADOPOULOS, M. MATSAGKAS CITATION: HERNIA. 2015; 19: 267 271. DOI: 10.1007/S10029-014-1262-4 OPEN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR IS FOLLOWED BY A HIGH RATE OF INCISIONAL HERNIATION. THE PURPOSE OF THIS PROSPECTIVE RANDOMIZED CLINICAL STUDY WAS TO EVALUATE WHETHER THIS POST-OPERATIVE COMPLICATION COULD BE AVOIDED BY A PROPHYLACTIC IMPLANTATION OF A BIOLOGICAL MESH. A TOTAL OF 40 PATIENTS UNDERWENT OPEN AAA AND WERE INCLUDED IN THE STUDY. OF WHICH, 20 PATIENTS WERE RANDOMIZED UNDER THE SUTURE FASCIA CLOSURE GROUP (GROUP A) AND 20 PATIENTS WERE RANDOMIZED UNDER SUTURE FASCIA CLOSURE REINFORCEMENT BY AN ONLAY MESH IMPLANTATION. IN THE SUTURE FASCIA CLOSURE GROUP, AFTER THE ANEURYSM SAC AND POSTERIOR PERITONEUM WAS CLOSED, A ROUTINE MASS CLOSURE IN A RUNNING 4:1 RATIO PDS 1-0 LOOP SUTURE WAS MADE. POST-OPERATIVE COMPLICATION INCLUDED SEROMA (N-1) WHICH WAS TREATED WITH PERCUTANEOUS DRAINAGE. IT WAS CONCLUDED THAT THE BOVINE PERICARDIUM MESH REINFORCEMENT OF FASCIA CLOSURE IN PATIENTS UNDERGOING OPEN AAA REPAIR SHOWED EFFECTIVENESS AND LOW COMPLICATION RATE IN PROPHYLAXIS FROM INCISIONAL HERNIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321131 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention