BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8885482 · Received August 12, 2019

    Report

    Report Number
    2210968-2019-85437
    Event Type
    Injury
    Date Received
    August 12, 2019
    Report Date
    August 2, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: AM J SURG. 1996; 172:315 ¿ 319. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: THE TENSION-FREE HERNIOPLASTY IN A RANDOMIZED TRIAL. THE AIM OF THE STUDY WAS A COMPARISON BETWEEN THE TWO RANDOMIZED GROUPS REGARDING RECURRENCE RATE; A RECURRENCE BEING DEFINED AS A BULGE OR WEAKNESS IN THE OPERATION AREA EXACERBATED BY A VALSALVA MANEUVER NECESSITATING FURTHER OPERATION OR PROVISION OF A TRUSS, RATE OF POSTOPERATIVE INFECTION AND HEMATOMA/SEROMA FORMATION, FREQUENCY OF LONG TERM SYMPTOMS FROM THE OPERATION AREA, POSTOPERATIVE TIME OFF WORK, AND THE INFLUENCE OF THE EXPERIENCE OF THE SURGEON ON RECURRENCE RATE IN BOTH RANDOMIZED GROUPS. DURING THE PERIOD FROM 01 DECEMBER 1990 THROUGH 28 FEBRUARY 1993, THE PATIENTS WERE GROUPED INTO TWO: TENSION-FREE HERNIOPLASTY (N=102) AND COOPER LIGAMENT REPAIR OR AN ANNULORRHAPIA (N=106); (AGE RANGE FOR BOTH GROUPS 23 - 85 YEARS WITH MEDIAN AGE 60 YEARS; FEMALE 11.5%). THE TENSION-FREE HERNIOPLASTY WAS PERFORMED AS DESCRIBED BY LICHTENSTEIN USING 6 X 11 CM PROLENE MESH (ETHICON) AND A CONTINUOUS 0-0 PROLENE SUTURE (ETHICON) TO RETAIN THE MESH IN THE DESIRED POSITION. THE COOPER LIGAMENT REPAIR AND ABDOMINAL RING REPAIR WERE BOTH PERFORMED AS DESCRIBED BY MCVAY USING 0 POLYGLYCOLIC ACID ABSORBABLE SUTURE (VICRYL, ETHICON) TO RECONSTRUCT THE POSTERIOR INGUINAL WALL, A RELAXING INCISION BEING OMITTED ONLY EXCEPTIONALLY IN THE DIRECT HERNIAS. RECURRENCE WERE OBSERVED IN TENSION-FREE HERNIOPLASTY (N=5) AND COOPER LIGAMENT REPAIR OR AN ANNULORRHAPIA (N=16). POSTOPERATIVE COMPLICATIONS IN TENSION-FREE HERNIOPLASTY INCLUDED HEMATOMA/SEROMA (N=4) AND PROLONGED PAIN (N=1); POSTOPERATIVE COMPLICATIONS IN COOPER LIGAMENT REPAIR OR AN ANNULORRHAPIA INCLUDED INFECTION (N=1) DEVELOPED 4 WEEKS AFTER OPERATION AND THE WOUND WAS OPENED; HEMATOMA/SEROMA (N=5). OF THE 9 PATIENTS WITH HEMATOMA/SEROMA, 6 WERE REOPERATED ON A FEW HOURS AFTER THE HERNIOTOMY DUE TO REBLEEDING, AND 3 WERE TREATED WITH ASPIRATION IN THE OUTPATIENT CLINIC. 1 PATIENT WITH PROLONGED PAIN IN THE OPERATION-AREA AFTER A TENSION-FREE REPAIR WAS REOPERATED ON 3 MONTHS AFTER THE HERNIOTOMY ON SUSPICION OF REHERNIATION. NO CAUSE FOR THE PAIN WAS FOUND, THE ILIOINGUINAL NERVE WAS INTACT, THE PROLENE MESH WAS LEFT IN SITU, AND THE SYMPTOMS SUBSIDED POSTOPERATIVELY. IN CONCLUSION, RECURRENCE RATE IS REDUCED TO ONE-THIRD AFTER TENSION-FREE HERNIOTOMIES WITHOUT INCREASE IN COMPLICATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677213 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention