BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL NU KNIT HEMO 7.5X10

    MDR report key: 8406054 · Received March 8, 2019

    Report

    Report Number
    2210968-2019-79380
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    November 13, 2018
    Report Date
    February 15, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    UDI-DI
    10705031002975
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE [NOT AVAILABLE] DATE OF THE INDEX SURGICAL PROCEDURE [(B)(6) 2018]. DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? [GRAVES¿ DISEASE]. PATIENT PRE-EXISTING MEDICAL CONDITIONS [NIL]. WHY WAS SURGICEL NU KNOT USED DURING THE INITIAL PROCEDURE? [HEMOSTASIS]. WAS EXCESS SURGICEL NU KNIT REMOVED AFTER RECEIVING HEMOSTASIS, DURING THE PROCEDURE? [ONLY A STAMP SIZE OF NU KNIT WAS PLACED BEFORE WOUND CLOSURE AND LEFT BEHIND IN THE OPERATION SITE]. DID THE PATIENT HAVE AN INFECTION? [YES]. WHAT WAS THE NATURE OF THE ASPIRATE? [PUS]. WERE PRE-OP ANTIBIOTICS ADMINISTERED? [NO]. WERE ANY CULTURES PERFORMED? IF YES, WHAT WAS THE RESULT? [GP G STREPTOCOCCI (HEAVY)]. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? [RELATED TO SURGICAL MATERIAL]. DOES THE SURGEON BELIEVE THAT THE SURGICEL NU KNIT WAS RELATED TO THE PATIENT¿S SYMPTOMS? [YES]. GIVEN THE SURGEON¿S EXPERIENCE WITH THIS PROCEDURE, WHY DOES THE SURGEON CONSIDER SURGICAL NU KNIT IS A FACTOR IN THE INFECTION? [IT WAS THE ONLY SURGICAL MATERIAL LEFT BEHIND]. WHY DOES THE SURGEON CONSIDER SURGICEL NU KNIT WHILE EXCLUDING OTHER FACTORS? [NO OTHER CAUSE OR CONTAMINATION IDENTIFIED.] IS THIS (INFECTION) A RECENT OBSERVATION? [NO]. HOW HAS THE NUMBER OF INFECTIONS CHANGED FROM PREVIOUS HISTORY OF INFECTIONS? [PREVIOUS INFECTION RATE: 1 IN 1500 CASES]. WHAT IS THE PATIENT¿S CURRENT STATUS? [RECOVERED].

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER LEB5122, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE DATE OF THE INDEX SURGICAL PROCEDURE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? PATIENT PRE-EXISTING MEDICAL CONDITIONS WHY WAS SURGICEL NU KNOT USED DURING THE INITIAL PROCEDURE? WAS EXCESS SURGICEL NU KNIT REMOVED AFTER RECEIVING HEMOSTASIS, DURING THE PROCEDURE? DID THE PATIENT HAVE AN INFECTION? WHAT WAS THE NATURE OF THE ASPIRATE? WERE PRE-OP ANTIBIOTICS ADMINISTERED? WERE ANY CULTURES PERFORMED? IF YES, WHAT WAS THE RESULT? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? DOES THE SURGEON BELIEVE THAT THE SURGICEL NU KNIT WAS RELATED TO THE PATIENT¿S SYMPTOMS? GIVEN THE SURGEON¿S EXPERIENCE WITH THIS PROCEDURE, WHY DOES THE SURGEON CONSIDER SURGICAL NU KNIT IS A FACTOR IN THE INFECTION? WHY DOES THE SURGEON CONSIDER SURGICEL NU KNIT WHILE EXCLUDING OTHER FACTORS? IS THIS (INFECTION) A RECENT OBSERVATION? HOW HAS THE NUMBER OF INFECTIONS CHANGED FROM PREVIOUS HISTORY OF INFECTIONS? WHAT IS THE PATIENT¿S CURRENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2018 AND ABSORBABLE HEMOSTAT DEVICE WAS USED. THE PATIENT HAD GRAVES' DISEASE. THE ABSORBABLE HEMOSTAT DEVICE WAS CUT INTO A STAMP SIZE AND PLACED IN THE OPERATION SITE BEFORE WOUND CLOSURE. THE PATIENT EXPERIENCED A POST OP INFECTION. ON POST-OP DAY 1, THE PATIENT SUFFERED FROM HIGH FEVER WITH NECK REDNESS AND SWELLING. THE PATIENT WAS TREATED WITH ASPIRATION OF PUS. ON POST-OP DAY 2, THE WOUND WAS EXPLORED WITH DRAINAGE OF 50ML PUS. THE PATIENT WAS KEPT IN THE HOSPITAL FOR MORE THAN TWO WEEKS FOR DRESSING WITH TREATMENT BY ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196015 SURGICEL NU KNIT HEMO 7.5X10 HEMOSTATIC AGENT, ABSORBABLE LMG ETHICON INC. LEB5122 10705031002975

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention