BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7654965 · Received July 2, 2018

    Report

    Report Number
    2210968-2018-73981
    Event Type
    Injury
    Date Received
    July 2, 2018
    Report Date
    June 7, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE INDICATE THE NUMBER OF PATIENTS WHO DEVELOPED INCISIONAL HERNIA, SUPERFICIAL WOUND INFECTION, DEEP WOUND INFECTION, ENTEROATMOSPHERIC FISTULA, SEROMA, AND HEMATOMA WITH THE USE OF THE ETHICON PRODUCTS (PROLENE 0 AND PDS 1-0 SUTURES) DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? IF YES, PLEASE EXPLAIN DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT USED IN THIS PROCEDURE? IF YES, PLEASE EXPLAIN. HAS THE COMPLAINT BEEN PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE COMPLAINT NUMBER. WEB ADDRESS: DOI 10.1007/S00464-013-3251-6/AC CITATION: SURG ENDOSC. 2014; 28: 735 740. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : DELAYED CLOSURE OF OPEN ABDOMEN IN SEPTIC PATIENTS IS FACILITATED BY COMBINED NEGATIVE PRESSURE WOUND THERAPY AND DYNAMIC FASCIAL SUTURE" AUTHOR : RENE´ H. FORTELNY ¿ ANNA HOFMANN ¿ SIMONE GRUBER-BLUM ¿ ALEXANDER H. PETTER-PUCHNER ¿ KARL S. GLASER. WEB ADDRESS: DOI 10.1007/S00464-013-3251-6/AC. CITATION: SURG ENDOSC. 2014; 28: 735 740. THE AIM OF THIS PROSPECTIVE CONTROLLED TRIAL WAS THE DEFINITION OF THE OPTIMAL TIMEPOINT FOR DELAYED CLOSURE AFTER NEGATIVE PRESSURE WOUND THERAPY (NPWT) IN THE TREATMENT OF THE OPEN ABDOMEN (OA) IN SEPTIC PATIENTS AFTER ABDOMINAL SURGERY. A TOTAL OF 87 PATIENTS (48 MALE AND 39 FEMALE; AGE RANGE: 25.2 TO 92.9) SUBJECTED TO OA THERAPY FOLLOWING SURGERY FOR SECONDARY PERITONITIS WERE TREATED WITH NPWT AND DYNAMIC FASCIAL SUTURES (DFS). IN THE DELAYED PRIMARY FASCIAL CLOSURE TECHNIQUE, AFTER SUCCESSFUL TREATMENT OF THE OA BY NPWT, THE EXTERNAL FASCIA WAS PREPARED FOR A TENSION-FREE CLOSURE TECHNIQUE. IN THE BEGINNING OF THE STUDY, THE CLOSURES WERE PERFORMED BY NON-RESORBABLE PROLENE 0 RUNNING SUTURES AND LATE RESORBABLE SUTURES (PDS 1-0 SUTURES, MAXONPLUS, AND MONOMAX). IN ORDER TO, MINIMIZE THE RISK OF ACUTE HERNIA DUE TO A HIGH TENSION, THE SUTURE TECHNIQUE AT THE START OF THE PROSPECTIVE STUDY CHANGED FROM ¿LARGE BITES¿ TO ¿SMALL BITES¿. IN THE LARGE BITES TECHNIQUE, THE SUTURE-TO-WOUND LENGTH RATIO WAS HIGHER, AT LEAST 4:1, WHEREAS IN THE SMALL BITES TECHNIQUE THE RATIO WAS AT LEAST 6:1. IF A TENSION-FREE CLOSURE COULD NOT BE ACHIEVED, ADDITIONAL ANTERIOR COMPONENT SEPARATION (ACS) WAS PERFORMED. IN SOME CASES A BULGING ON THE SITE OF ACS APPEARED. IN THESE CASES, A PROPHYLACTIC ONLAY MESH REINFORCEMENT WAS ACCOMPLISHED. REPORTED COMPLICATIONS INCLUDED SUPERFICIAL WOUND INFECTION (N-15; 17.2%), DEEP WOUND INFECTION (N-2; 2.3%), ENTEROATMOSPHERIC FISTULA (N-3; 3.4%), SEROMA (5.7%), HEMATOMA (2.3%). IT WAS CONCLUDED THAT AN EARLY SUCCESSFUL DELAYED FASCIAL CLOSURE BY ELASTIC, LATE RESORBABLE, RUNNING SUTURE IN SMALL BITES TECHNIQUE, WITH LOW RISK OF BURST ABDOMEN AND INCISIONAL HERNIA, CAN BE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496455 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROLENE SUTURE