BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 16525196 · Received March 10, 2023

    Report

    Report Number
    1219930-2023-00942
    Event Type
    Injury
    Date Received
    March 10, 2023
    Date of Event
    February 1, 2023
    Report Date
    March 29, 2023
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE: POSTOPERATIVE VAGINAL BLEEDING CONCERNS AFTER GENDER-AFFIRMING HYSTERECTOMY IN TRANSGENDER ADOLESCENTS AND YOUNG ADULTS ON TESTOSTERONE SOURCE: 2022 NORTH AMERICAN SOCIETY FOR PEDIATRIC AND ADOLESCENT GYNECOLOGY. PUBLISHED BY ELSEVIER INC. HTTPS://DOI.ORG/10.1016/J.JPAG.2022.09.002. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A4, B5, G3, H6 NEW INFORMATION HAS BEEN RECEIVED, AND REASSESSMENT OF THE COMPLAINT FOUND THAT IT IS NO LONGER A REPORTABLE EVENT. THE EVENT IS NO LONGER ASSOCIATED WITH A SERIOUS INJURY OR POTENTIAL FOR SERIOUS INJURY WITH REOCCURRENCE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED POSTOPERATIVE VAGINAL BLEEDING IN PATIENTS WHO UNDERWENT A MINIMALLY IN VASIVE GENDER AFFIRMING HYSTERECTOMY BETWEEN (B)(6) 2020 AND (B)(6) 2021. IN THE LAPAROSCOPIC GROUP, VAGINAL CUFF CLOSURE WAS PERFORMED WITH 2-0 V-LOC SUTURES IN A CONTINUOUS FASHION AND IN THE VAGINAL APPROACH, A COMPETITOR SUTURE WAS USED. THERE WERE 25 PATIENTS IN THE STUDY, 15 PATIENTS IN THE LAPAROSCOPIC GROUP AND 9 PATIENTS IN THE VAGINAL GROUP. POSTOPERATIVE COMPLICATIONS IN EIGHT PATIENTS FROM THE LAPAROSCOPIC GROUP AND FIVE FROM THE VAGINAL APPROACH INCLUDED VAGINAL BLEEDING AND A BLEEDING SUBMUCOSAL VESSEL WAS OBSERVED IN ONE PATIENT. MOST CASES OF BLEEDING WERE MILD AND NEARLY HALF OF CASES SELF-RESOLVED WITHOUT INTERVENTION; AND EXAMINATION UNDER ANESTHESIA AND REOPERATION WITH OVERSEWING OF THE VAGINAL CUFF WAS REQUIRED TO MANAGE BLEEDING IN TWO PATIENTS. IT WAS NOTED THAT PATIENTS WITH VAGINAL BLEEDING CONCERNS DID HAVE A HIGHER FREQUENCY OF CURRENT OR FORMER TOBACCO USE, WHICH IS KNOWN TO ADVERSELY IMPACT THE SURGICAL WOUND-HEALING PROCESS VIA IMPAIRED TISSUE OXYGENATION AND EPITHELIALIZATION.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED POSTOPERATIVE VAGINAL BLEEDING IN PATIENTS WHO UNDERWENT A MINIMALLY IN VASIVE GENDER AFFIRMING HYSTERECTOMY BETWEEN (B)(6) 2020 AND (B)(6) 2021. IN THE LAPAROSCOPIC GROUP, VAGINAL CUFF CLOSURE WAS PERFORMED WITH 2-0 V-LOC SUTURES IN A CONTINUOUS FASHION AND IN THE VAGINAL APPROACH, A COMPETITOR SUTURE WAS USED. THERE WERE 25 PATIENTS IN THE STUDY, 15 PATIENTS IN THE LAPAROSCOPIC GROUP AND 9 PATIENTS IN THE VAGINAL GROUP. POSTOPERATIVE COMPLICATIONS IN EIGHT PATIENTS FROM THE LAPAROSCOPIC GROUP AND FIVE FROM THE VAGINAL APPROACH INCLUDED VAGINAL BLEEDING AND A BLEEDING SUBMUCOSAL VESSEL WAS OBSERVED IN ONE PATIENT. MOST CASES OF BLEEDING WERE MILD AND NEARLY HALF OF CASES SELF-RESOLVED WITHOUT INTERVENTION; AND EXAMINATION UNDER ANESTHESIA AND REOPERATION WITH OVERSEWING OF THE VAGINAL CUFF WAS REQUIRED TO MANAGE BLEEDING IN TWO PATIENTS. IT WAS NOTED THAT PATIENTS WITH VAGINAL BLEEDING CONCERNS DID HAVE A HIGHER FREQUENCY OF CURRENT OR FORMER TOBACCO USE, WHICH IS KNOWN TO ADVERSELY IMPACT THE SURGICAL WOUND-HEALING PROCESS VIA IMPAIRED TISSUE OXYGENATION AND EPITHELIALIZATION. THE REPORTER CONFIRMED THAT THE COMPLICATIONS WERE NOT DEVICE-RELATED. ARTICLE: POSTOPERATIVE VAGINAL BLEEDING CONCERNS AFTER GENDER-AFFIRMING HYSTERECTOMY IN TRANSGENDER ADOLESCENTS AND YOUNG ADULTS ON TESTOSTERONE AUTHOR: DANIELLE T. CIPRES, JESSICA Y. SHIM1, FRANCES W. GRIMSTAD YEAR: 2023 PUBLICATION: ELSEVIER INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473488 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Required Intervention