BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK BRD BLK 15X60CM M2.0

    MDR report key: 9498129 · Received December 19, 2019

    Report

    Report Number
    2210968-2019-91124
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    September 6, 2019
    Report Date
    December 2, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 02/12/2020. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ALL THE ANSWERS FOR THE BELOW QUESTIONS ARE UNOBTAINABLE. THE PATIENT DEMOGRAPHIC INFO: AGE, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WHAT WAS THE DATE OF THE INITIAL PROCEDURE? WHERE WAS THE LOCATION OF THE TUMOR THAT WAS REMOVED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WERE ANY CULTURES PERFORMED OF THE WOUND SECRETION? IF SO, WHAT ARE THE RESULTS? WHAT WAS THE DATE OF THE SUTURE REMOVAL AND LOCAL DEBRIDEMENT PROCEDURE? WHAT WAS THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS IF APPLICABLE, WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S CURRENT STATUS?

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 1/15/2020. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (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: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THREE POSSIBLE BATCH NUMBERS ARE REPORTED AS FOLLOWS: BATCH PE1AS MFG DATE: 5/05/2019, EXP DATE: 4/30/2024. BATCH 240430 MFG DATE: UNK, EXP DATE: UNK. 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, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WHAT WAS THE DATE OF THE INITIAL PROCEDURE? WHERE WAS THE LOCATION OF THE TUMOR THAT WAS REMOVED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WERE ANY CULTURES PERFORMED OF THE WOUND SECRETION? IF SO, WHAT ARE THE RESULTS? WHAT WAS THE DATE OF THE SUTURE REMOVAL AND LOCAL DEBRIDEMENT PROCEDURE? WHAT WAS THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE? WHAT IS THE PRODUCT CODE? CAN YOU CLARIFY IF THESE ARE POSSIBLE LOTS INVOLVED AS LOT 240430 OR LOT PE1AS? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS. IF APPLICABLE, WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION. WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S CURRENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXCISION OF TUMOR PROCEDURE ON UNKNOWN DATE IN (B)(6) 2019 AND SUTURE WAS USED. THE PATIENT WAS GIVEN CLEANNESS AND DRESSING CHANGE DAILY AFTER THE SURGERY. THE PATIENT EXPERIENCED LOCAL ERYTHEMA, INFLAMMATION AND WOUND SECRETION ON THE INCISION 7 DAYS POST PROCEDURE. THE DOCTOR REMOVED THE SUTURE AND ENHANCED LOCAL DEBRIDEMENT AND DRESSING CHANGE WERE GIVEN. THE SYMPTOMS GRADUALLY IMPROVED AFTER 2 DAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291483 SILK BRD BLK 15X60CM M2.0 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. PE1AS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention