BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9536238 · Received December 31, 2019

    Report

    Report Number
    2210968-2019-91423
    Event Type
    Injury
    Date Received
    December 31, 2019
    Report Date
    December 9, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. POLYPROPOLENE SUTURE CAPTURED IN MW 2210968-2019-91421. CITATION: DIS COLON RECTUM (2002);45:360¿369. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: EARLY EXPERIENCE WITH STAPLED HEMORRHOIDECTOMY IN THE UNITED STATES" AUTHORS: MARC A. SINGER, M.D., JOSE R. CINTRON, M.D., JAMES W. FLESHMAN, M.D., VIVEK CHAUDHRY, M.D., ELISA H. BIRNBAUM, M.D., THOMAS E. READ, M.D., JAMES S. SPITZ, M.D., HER AND ABCARIAN, M.D. CITATION: DIS COLON RECTUM (2002);45:360¿369. THE AUTHORS REPORTED THE EARLY RESULTS OF PATIENTS TREATED WITH STAPLED HEMORRHOIDECTOMY, WHICH HAS RECENTLY BEEN INTRODUCED INTO THE UNITED STATES. THIS PROSPECTIVE STUDY INVOLVES 68 PATIENTS (45 MALE AND 23 FEMALE; MEAN AGE: 56 YEARS; AGE RANGE: 29 TO 92 YEARS) WHO UNDERWENT STAPLED HEMORRHOIDECTOMIES DURING THE PERIOD FROM DECEMBER 1999 THROUGH MAY 2000. THE PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER (ETHICON) AND INCLUDED SUPPLIES WERE USED FOR ALL OPERATIONS. A 0 PROLENE® (POLYPROPYLENE) SUTURE ON A CT2 NEEDLE (ETHICON) WAS PLACED APPROXIMATELY 2 CM PROXIMAL TO THE APEX OF THE HEMORRHOIDS INTO THE MUCOSA AND SUBMUCOSA ONLY. IF BLEEDING WAS PRESENT, THEN 3-0 VICRYL SUTURES (ETHICON) WERE USED TO OVERSEW THE AREAS OF BLEEDING. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE PAIN DAY 1 (N-58), POST OPERATIVE PAIN DAY 7 (N-57), INCOMPLETE DOUGHNUT (N-4) WHICH WAS OVERSEWN WITH ABSORBABLE SUTURES, STAPLER MALFUNCTION (N-1) IN WHICH THE STAPLER WAS REMOVED AND A NEW STAPLER WAS PASSED ACROSS THE ORIGINAL PURSESTRING SUTURE AND THE OPERATION WAS COMPLETED WITHOUT DIFFICULTY, STAPLE LINE HAD BEEN INCOMPLETE (N-1) IN WHICH ADDITIONAL SUTURE WERE PLACED AT THE AREA AND THE PATIENT REQUIRED NO FURTHER THERAPY, LEVATOR SPASM (N-2) WHICH WERE EASILY TREATED WITH ORAL MUSCLE RELAXANTS, SEPARATION OF THE STAPLE LINE/PARTIAL DISRUPTION OF THE STAPLE LINE/STAPLE LINE DEHISCED (N-1) IN WHICH THE PATIENT DID NOT REQUIRE FURTHER SURGICAL THERAPY, PERSISTENT PROLAPSE (N-5) IN WHICH 1 PATIENT HAD AN EXCISIONAL HEMORRHOIDECTOMY ELSEWHERE AND WAS UNAVAILABLE FOR FOLLOW-UP EXAMINATION AND 2 PATIENTS HAD RUBBER BAND LIGATION, PERSISTENT BLEEDING (N-3) IN WHICH 2 PATIENTS HAD RUBBER BAND LIGATION, AND PERSISTENT ITCHING (N-3). IN CONCLUSION, STAPLED HEMORRHOIDECTOMY IS SAFE, EFFECTIVE, AND CAN BE PERFORMED AS AN OUTPATIENT PROCEDURE WITH LOCAL OR REGIONAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330927 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention