BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 12799450 · Received November 11, 2021

    Report

    Report Number
    2210968-2021-11310
    Event Type
    Injury
    Date Received
    November 11, 2021
    Date of Event
    December 6, 2020
    Report Date
    November 11, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 CITE: HTTPS://DOI.ORG/10.1016/J.JMIG.2020.12.007 WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS (GYNECARE GYNEMESH, PDS II, ETHIBOND, AND MONOCRYL SUTURES) 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 INVOLVED? PATIENT DEMOGRAPHICS? EVENT RELATED TO THE GYNECARE GYNEMESH REPORTED VIA MW # 2210968-2021-11308. EVENT RELATED TO THE PDS II SUTURE REPORTED VIA MW # 2210968-2021-11309. EVENT RELATED TO THE MONOCRYL SUTURE REPORTED VIA MW # 2210968-2021-11311.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEVICE NOT RETURNED. 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 CITE: HTTPS://DOI.ORG/10.1016/J.JMIG.2020.12.007 WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS ((B)(6) GYNEMESH, PDS II, ETHIBOND, AND MONOCRYL SUTURES) 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 INVOLVED? PATIENT DEMOGRAPHICS? EVENT RELATED TO THE (B)(6) GYNEMESH REPORTED VIA MW # 2210968-2021-11308. EVENT RELATED TO THE PDS II SUTURE REPORTED VIA MW # 2210968-2021-11309. EVENT RELATED TO THE MONOCRYL SUTURE REPORTED VIA MW # 2210968-2021-11311.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PERI- AND POSTOPERATIVE OUTCOMES OF OUTPATIENT VS INPATIENT LAPAROSCOPIC APICAL PROLAPSE REPAIR. THE AIM OF THIS STUDY WAS TO REPORT OUR EXPERIENCE AND PATIENT OUTCOMES AFTER OUTPATIENT LAPAROSCOPIC APICAL PROLAPSE REPAIR AND TO COMPARE THE PERIOPERATIVE OUTCOMES OF WOMEN ADMITTED WITH THOSE DISCHARGED ON THE DAY OF SURGERY. A RETROSPECTIVE COHORT STUDY WAS PERFORMED INCLUDING ALL PATIENTS WHO UNDERWENT A LAPAROSCOPIC SACROCERVICO- OR SACROCOLPOPEXY WITH OR WITHOUT HYSTERECTOMY, ALONG WITH VAGINAL PROLAPSE AND ANTI-INCONTINENCE PROCEDURES AS INDICATED FROM 2013 TO 2017 AS A COMBINED PROCEDURE BETWEEN MINIMALLY INVASIVE GYNECOLOGIC SURGERY (MIGS) AND FEMALE PELVIC MEDICINE AND RECONSTRUCTIVE SURGERY (FPMRS) PHYSICIANS AT BRIGHAM & WOMEN¿S HOSPITAL AND BRIGHAM & WOMEN¿S FAULKNER HOSPITAL. APICAL SUSPENSION WAS PERFORMED USING A EITHER A PREPACKAGED GYNECARE GYNEMESH (ETHICON, INC., JOHNSON AND JOHNSON, SOMERVILLE, NJ). THE MESH WAS SECURED TO THE ANTERIOR AND POSTERIOR CERVIX AND/OR VAGINA WITH 6 INTERRUPTED SUTURES OF 2-0 PDS (OR 2-0 ETHIBOND; ETHICON, SOMERVILLE, NJ) ANTERIORLY AND 6 SUTURES POSTERIORLY, TYING KNOTS INTRACORPOREALLY. THE MESH WAS THEN COMPLETELY RETROPERITONEALIZED USING 2-0 MONOCRYL SUTURE (ETHICON, SOMERVILLE, NJ). MIDURETHRAL SLINGS, ANTERIOR COLPORRHAPHY, AND POSTERIOR COLPOPERINEORRHAPHY WERE ADDITIONALLY PERFORMED AS INDICATED BY THE FPMRS TEAM IN THE USUAL FASHION. REPORTED COMPLICATIONS INCLUDED CLAVIEN-DINDO GRADE 1 OR 2 (N=5), URINARY RETENTION THAT REQUIRED DISCHARGE WITH A CATHETER. VAGINAL BLEEDING AND SUTURE SEPARATION IN THE PROXIMAL POSTERIOR COLPORRHAPHY REPAIR (N=2), REOPERATED ON AND RETURNED TO THE OPERATING ROOM, AND THE AREA WAS SUTURED. THE OTHER PATIENT UNDERWENT THE EXCISION OF A PERINEAL SKIN TAG WITH PLACEMENT OF THE SUTURE UNDER LOCAL ANESTHESIA IN THE OFFICE ON POSTOPERATIVE DAY 6. ABDOMINAL PAIN AND DISTENSION NOTED TO HAVE SEVERE URINARY RETENTION WITH A DISTENDED BLADDER (N=2) AND WAS READMITTED ON POSTOPERATIVE DAY 5 AND WAS DISCHARGED WITH A FOLEY CATHETER. IN CONCLUSION LAPAROSCOPIC APICAL PROLAPSE REPAIR WITH CONCOMITANT VAGINAL REPAIRS CAN BE PERFORMED SAFELY AS AN OUTPATIENT PROCEDURE. A UNIQUE TEAM APPROACH MAY FOSTER A SHORTER, MORE EFFICIENT PROCEDURE WITHOUT COMPROMISING SHORT-TERM OUTCOMES.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PERI- AND POSTOPERATIVE OUTCOMES OF OUTPATIENT VS INPATIENT LAPAROSCOPIC APICAL PROLAPSE REPAIR. THE AIM OF THIS STUDY WAS TO REPORT OUR EXPERIENCE AND PATIENT OUTCOMES AFTER OUTPATIENT LAPAROSCOPIC APICAL PROLAPSE REPAIR AND TO COMPARE THE PERIOPERATIVE OUTCOMES OF WOMEN ADMITTED WITH THOSE DISCHARGED ON THE DAY OF SURGERY. A RETROSPECTIVE COHORT STUDY WAS PERFORMED INCLUDING ALL PATIENTS WHO UNDERWENT A LAPAROSCOPIC SACROCERVICO OR SACROCOLPOPEXY WITH OR WITHOUT HYSTERECTOMY, ALONG WITH VAGINAL PROLAPSE AND ANTI-INCONTINENCE PROCEDURES AS INDICATED FROM 2013 TO 2017 AS A COMBINED PROCEDURE BETWEEN MINIMALLY INVASIVE GYNECOLOGIC SURGERY (MIGS) AND FEMALE PELVIC MEDICINE AND RECONSTRUCTIVE SURGERY (FPMRS) PHYSICIANS AT (B)(6) HOSPITAL. APICAL SUSPENSION WAS PERFORMED USING A EITHER A PREPACKAGED (B)(6) GYNEMESH (ETHICON, INC., (B)(6)). THE MESH WAS SECURED TO THE ANTERIOR AND POSTERIOR CERVIX AND/OR VAGINA WITH 6 INTERRUPTED SUTURES OF 2-0 PDS (OR 2-0 ETHIBOND; ETHICON, (B)(6), NJ) ANTERIORLY AND 6 SUTURES POSTERIORLY, TYING KNOTS INTRACORPOREALLY. THE MESH WAS THEN COMPLETELY RETROPERITONEALIZED USING 2-0 MONOCRYL SUTURE (ETHICON, (B)(6), NJ). MIDURETHRAL SLINGS, ANTERIOR COLPORRHAPHY, AND POSTERIOR COLPOPERINEORRHAPHY WERE ADDITIONALLY PERFORMED AS INDICATED BY THE FPMRS TEAM IN THE USUAL FASHION. REPORTED COMPLICATIONS INCLUDED CLAVIEN-DINDO GRADE 1 OR 2 (N=5), URINARY RETENTION THAT REQUIRED DISCHARGE WITH A CATHETER. VAGINAL BLEEDING AND SUTURE SEPARATION IN THE PROXIMAL POSTERIOR COLPORRHAPHY REPAIR (N=2), REOPERATED ON AND RETURNED TO THE OPERATING ROOM, AND THE AREA WAS SUTURED. THE OTHER PATIENT UNDERWENT THE EXCISION OF A PERINEAL SKIN TAG WITH PLACEMENT OF THE SUTURE UNDER LOCAL ANESTHESIA IN THE OFFICE ON POSTOPERATIVE DAY 6. ABDOMINAL PAIN AND DISTENSION NOTED TO HAVE SEVERE URINARY RETENTION WITH A DISTENDED BLADDER (N=2) AND WAS READMITTED ON POSTOPERATIVE DAY 5 AND WAS DISCHARGED WITH A FOLEY CATHETER. IN CONCLUSION LAPAROSCOPIC APICAL PROLAPSE REPAIR WITH CONCOMITANT VAGINAL REPAIRS CAN BE PERFORMED SAFELY AS AN OUTPATIENT PROCEDURE. A UNIQUE TEAM APPROACH MAY FOSTER A SHORTER, MORE EFFICIENT PROCEDURE WITHOUT COMPROMISING SHORT-TERM OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692241 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention