BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL+ UD 27IN 3-0 S/A SH

    MDR report key: 10202890 · Received June 26, 2020

    Report

    Report Number
    2210968-2020-04878
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    January 1, 2020
    Report Date
    May 29, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031053014
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 07/21/2020. CORRECTED INFORMATION: D8. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PA2803, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ANY MEDICAL TREATMENT PROVIDED? IF YES, PLEASE PROVIDE MEDICINE NAME, STRENGTH AND DOSE WAS ANY SURGICAL INTERVENTION PERFORMED SPECIFICALLY RE-SUTURING? EXPLAIN TISSUE ON WHICH WAS USED? WHAT WAS THE NAME OF THE PROCEDURE? WHAT IS THE PROCEDURE DATE AND EVENT DAY? DATE AND NAME OF THE PROCEDURE? DATES ARE UNKNOWN, PROCEDURE NAME IS ¿WIDE EXCISION IN OS¿A OS PROCEDURE MEANS ¿ WIDE EXCISION CASES THAT ARE DONE IN OS SPECIALTY, SPECIFIC NAME IS NOT DECIDED. IT WAS REPORTED THAT "SUTURE HAS NOT BEEN ABSORBED AFTER 3 WEEKS OF SURGERY" " AND "SUB-Q WAS FOUND OUT TO BE OPEN DESPITE OF SUTURING". PLEASE CLARIFY THESE EVENTS. -- DEHISCENCE OCCURRED ALONG SUTURE LINE. SOME KNOTS THAT WERE MADE IN SUB-Q WERE OUT FROM THE SKIN WAS THE SUTURE USED ON SUBCUTANEOUS LAYER? YES VICRYL PLUS SUTURE WAS USED ON SUB-Q. FOR SKIN LAYER, EITHER SKIN STAPLER OR ETHILON WAS USED. WAS THE DEHISCENCE NOTED? SOME. DATE AND LOCATION OF INFLAMMATION WAS NOTED? YES. NOTES WERE ASKED TO BE SHARED BUT IT WILL TAKE SOME TIME. ANY PRESCRIBED MEDICATION/ TREATMENT PROVIDED? IF YES, PLEASE PROVIDE MEDICINE NAME, STRENGTH AND DOSE: ANTIBIOTICS WERE PROVIDED. WAS ANY SURGICAL INTERVENTION PERFORMED SPECIFICALLY RE-SUTURING? -- RESUTURING WAS DONE. WOUNDED SUTURE WAS REMOVED. NOTE: THIS MW REPORT #2210968-2020-04878 REPLACES EVENT ORIGINALLY REPORTED IN MW# 2210968-2020-04083. ALL INFORMATION RELATED TO THIS EVENT WILL BE REPORTED VIA MW# 2210968-2020-04878.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OS WIDE EXCISION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT MAY HAVE EXPERIENCED SUTURE NOT ABSORBED THREE WEEKS FROM THE PROCEDURE. THE PATIENT MAY HAVE EXPERIENCED SUB-Q TISSUE OPEN AFTER THE PROCEDURE AND THE SUTURE DID NOT HOLD THE WOUND ENOUGH. DEHISCENCE MAY HAVE OCCURRED ALONG THE SUTURE LINE AND SOME KNOTS THAT WERE MADE IN SUB-Q WERE OUT FROM THE SKIN. ANTIBIOTICS WERE PROVIDED. THE PATIENT ALSO EXPERIENCED INFLAMMATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE AND DEVICE WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667562 VCL+ UD 27IN 3-0 S/A SH SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP416H PA2803 10705031053014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention