BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VCL+ VIO 27IN 2-0 S/A SH

    MDR report key: 10081324 · Received May 21, 2020

    Report

    Report Number
    2210968-2020-04091
    Event Type
    Injury
    Date Received
    May 21, 2020
    Report Date
    May 13, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031052253
    PMA / PMN Number
    K132580
    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: 07/14/2020. ADDITIONAL INFORMATION: B1. 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. EVENTS SUBMITTED VIA 2210968-2020-04091, 2210968-2020-05287, 2210968-2020-05288, 2210968-2020-05289, 2210968-2020-05290, 2210968-2020-05291 AND 2210968-2020-05293.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 6/25/2020. CORRECTED INFORMATION: B1, B2, H1. ADDITIONAL INFORMATION: A1, A2, A3. ADDITIONAL H6 PATIENT CODE: 3189 ¿ SURGICAL INTERVENTION; 3191 - DEVICE EXTRUSION. ADDITIONAL H6 DEVICE CODE: 2993. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: OS PROCEDURE MEANS ¿ WIDE EXCISION CASES THAT ARE DONE IN OS SPECIALTY, SPECIFIC NAME IS NOT DECIDED.¿ CUSTOMER CANNOT CLEARLY MATCH WHICH PRODUCT IS USED TO WHICH PATIENT. PATIENT 6) 43/ M. DATE AND NAME OF THE PROCEDURE? UNKNOWN, PROCEDURE NAME IS ¿WIDE EXCISION IN OS.¿ 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. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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, AND NO NON-CONFORMANCES WERE IDENTIFIED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO CLARIFY THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DATE AND NAME OF THE PROCEDURE? 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 WERE BOTH EVENTS OCCURRED ON ONE PATIENT? WHEN WAS "SUB-Q FOUND OUT TO BE OPEN DESPITE OF SUTURING"? WAS THE SUTURE USED ON SUBCUTANEOUS LAYER? WAS THE DEHISCENCE NOTED? DATE AND LOCATION OF INFLAMMATION WAS NOTED? ANY PRESCRIBED MEDICATION/ TREATMENT PROVIDED? IF YES, PLEASE PROVIDE MEDICINE NAME, STRENGTH AND DOSE WAS ANY SURGICAL INTERVENTION PERFORMED SPECIFICALLY RE-SUTURING?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE HAS NOT BEEN ABSORBED AFTER 3 WEEKS FROM SURGERY AND SUB-Q WAS FOUND OUT TO BE OPEN DESPITE OF SUTURING. THE PATIENT EXPERIENCED ALSO INFLAMMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541464 VCL+ VIO 27IN 2-0 S/A SH SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP317H PG2777 10705031052253

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention