BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL RAPIDE ABS SUR SUT SYN

    MDR report key: 7864526 · Received September 11, 2018

    Report

    Report Number
    2210968-2018-75770
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    August 17, 2018
    Report Date
    August 24, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PC-(B)(4). DATE SENT TO THE FDA: (B)(4) 2018. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DATE OF PROCEDURE-(B)(4) 2018 TISSUE-SKIN CONDITION-NORMAL SUTURE PLACED-CONTINOUS SYMPTOMS-REDNESS&FLUID ON SKIN CULTURE-YES BUT NOT GET RESULT AGE-(B)(4) ,WEIGHT-(B)(4) ,NORMAL MEDICAL INTERVENTION-STERILIZATION SURGEONS OPINION-NO CONDITION-NORMAL

    Additional Manufacturer Narrative · 1

    PC-(B(4). WE RECEIVED 3 OPENED SBF FOLDER FOR CODE (B)(4). COMPLAINT SAMPLE FOIL PACK WAS NOT RETURNED HENCE LOT NUMBER OF COMPLAINT SAMPLE WAS NOT TRACED. ALONG WITH COMPLAINT SAMPLE WE RECEIVED 3 PIECES OF SUTURE AND NEEDLE. THE RETURNED SUTURES WERE OBSERVED IN PARTIALLY DISINTEGRATED CONDITION. RETURNED NEEDLE WERE INSPECTED WITH MAGNIFICATION AND NO ANY DEFECT WAS OBSERVED. SIX RETAIN SAMPLES OF THE INCIDENT CODE AND LOT NUMBER WAS RETRIEVED FOR ANALYSIS. THE PRIMARY PACKS OF RETAIN SAMPLES WERE VISUALLY INSPECTED FOR ATTRIBUTE DEFECTS LIKE PSEUDO SEAL, PIN HOLE, PRODUCT IN SEAL, PRESS MARKS ON PACK, DAMAGED PACKS BUT NO SUCH DEFECTS WERE OBSERVED. THE RETAIN SAMPLES WERE TESTED FOR STERILITY TEST AS PER USP GUIDELINES. THE INCIDENT LOT HAS UNDERGONE STERILIZATION BY GAMA RADIATION PROCESS. THE STERILIZATION RUN REPORT WAS REVIEWED AND FOUND TO MEET THE SPECIFICATION. ALL THE STERILIZATION PARAMETERS WERE OBSERVED TO BE WITHIN LIMITS AS SPECIFIED IN THE PROCESS SPECIFICATIONS FROM THE ABOVE ANALYSIS IT IS EVIDENT THAT THERE WAS NO ISSUE RELATED TO THE NEEDLE & SUTURE STERILITY, QUALITY AND PROCESSING OF THIS INCIDENT LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. 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. ATTEMPTS ARE BEING MADE TO OBTAIN 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. WHAT WAS THE DATE OF THE PROCEDURE? WHAT TISSUE WAS EACH OF THE 3 SUTURE USED ON? WHAT WAS THE CONDITION OF THE TISSUE DURING INITIAL PROCEDURE? HOW WAS SUTURE PLACED (CONTINUOUS OR INTERRUPTED)? WHAT WERE THE PATIENT SYMPTOMS? WERE ANY CULTURES TAKEN OF THE WOUND AND RESULTS? WHAT ARE THE PATIENT AGE, WEIGHT, PRIOR MEDICAL HISTORY? WHAT MEDICAL INTERVENTION WAS PERFORMED TO TREAT THE INFECTION? WHAT IS THE SURGEON¿S OPINION AS TO THE CONTRIBUTING FACTOR TO THE PATIENT EVENT? WHAT IS THE PATIENT CURRENT CONDITION?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT C-SECTION AND HYSTERECTOMY PROCEDURE ON UNKNOWN DATE IN (B)(6) 2018 AND SUTURE WAS USED. ONE WEEK POST OP, THE PATIENT EXPERIENCED INFECTION WITH REDNESS AND FLUID ON THE SKIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705709 VICRYL RAPIDE ABS SUR SUT SYN SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. T7021

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention