BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 9285369 · Received November 6, 2019

    Report

    Report Number
    2210968-2019-89601
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    November 1, 2017
    Report Date
    October 11, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #:(B)(4). (B)(4). 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: AS EXPLAINED BEFORE, I¿VE DECIDED TO OPEN THE COMPLAINT IN MY NAME BECAUSE THE PATIENT¿S MOTHER DOES NOT WANT TO PROVIDE ANY ADDITIONAL INFORMATION. DATE OF INCIDENT EVENT: WHEN WAS THE PATIENT HOSPITALIZED? NOT INFORMED. CITY WHERE THE HOSPITAL IS: SÃO PAULO. STATE WHERE THE HOSPITAL IS: SÃO PAULO. PRODUCT CODE MONOCRYL: LOT: NOT INFORMED. RESPONSIBLE REPRESENTATIVE WHO SOLD THE PRODUCT: NOT INFORMED. WHAT IS THE CURRENT STATUS OF THE PATIENT? HE IS FINE NOW. IS THERE A RETURN PRODUCT AVAILABLE FOR REVIEW? NO. I DO NOT HAVE ANY OTHER INFORMATION ABOUT THIS CASE. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: IF IN YOUR POSSESSION, MAY WE HAVE A COPY OF YOUR OPERATIVE REPORT? DOES ETHICON HAVE YOUR PERMISSION TO CONTACT YOUR SURGEON, IN THE EVENT ETHICON WOULD LIKE TO CONTACT YOUR SURGEON FOR MORE CLINICAL INFORMATION TO BE USED FOR A PRODUCT QUALITY COMPLAINT INVESTIGATION?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN NOVEMBER 2017 AND SUTURE WAS USED. THE PATIENT DEVELOPED A REJECTION IN THE THREAD THAT CREATED A LOCAL AND INTERNAL INFLAMMATORY PROCESS. THE PATIENT DEVELOPED INFECTION, NOTED AS SKIN BACTERIUM OF STAPHYLOCOCCUS AUREUS, WHICH EXTENDED THE HOSPITALIZATION FOR 2 MONTHS. ON AN UNKNOWN DATE THE PATIENT UNDERWENT A SECOND PROCEDURE TO REMOVE AND REPLACE THE SUTURE WITH A DIFFERENT TYPE. THEN THERE WAS THAT THERE WAS HEALING AT THE SURGICAL SITE. AT THE END OF JANUARY THE PATIENT WILL UNDERGO ANOTHER ORTHOPEDIC PROCEDURE USING AN ABSORBABLE SUTURE. PATIENT CONDITION IS REPORTED AS FINE CURRENTLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080564 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention