BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK BRD BLK 15X60CM M2.5

    MDR report key: 11007928 · Received December 15, 2020

    Report

    Report Number
    2210968-2020-09912
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    November 7, 2020
    Report Date
    November 30, 2020
    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

    DATE SENT TO THE FDA: 01/12/2021 ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ONSET DATE OF SYMPTOMS FROM THE PROCEDURE?-- (B)(6) 2020, WHICH IS THREE DAYS AFTER SEWING PLEASE CLARIFY/SPECIFY ¿SYMPTOMATIC TREATMENT OF PRESCRIBE ORAL MEDICINE¿? -------ORAL MEDICATION WAS GIVEN, BUT THE NAME OF THE MEDICINE IS UNOBTAINABLE. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: THE PATIENT DEMOGRAPHIC INFO: WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? WHAT BODY PART/LOCATION OF SKIN CONTUSION AND LACERATION? ON WHAT TISSUE WAS THE SILK SUTURE USED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFLAMMATION/INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING THE SUTURE PLACEMENT AND/OR DURING SUTURE REMOVAL? WHAT WAS USED FOR RE-SUTURING? OTHER RELEVANT PATIENT FACTORS/COMORBIDITIES/CONCOMITANT MEDICATIONS? WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S CURRENT STATUS? 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS REVIEWED, AND NO ISSUE FOUND. (B)(4). 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. THE PATIENT DEMOGRAPHIC INFO: WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? WHAT BODY PART/LOCATION OF SKIN CONTUSION AND LACERATION? ONSET DATE OF SYMPTOMS FROM THE PROCEDURE? ON WHAT TISSUE WAS THE SILK SUTURE USED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFLAMMATION/INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING THE SUTURE PLACEMENT AND/OR DURING SUTURE REMOVAL? PLEASE CLARIFY/SPECIFY ¿SYMPTOMATIC TREATMENT OF PRESCRIBE ORAL MEDICINE¿? WHAT WAS USED FOR RE-SUTURING? OTHER RELEVANT PATIENT FACTORS/COMORBIDITIES/CONCOMITANT MEDICATIONS? WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT¿S CURRENT STATUS? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DEBRIDEMENT ALONG WITH SKIN CONTUSION AND LACERATION REPAIR PROCEDURE ON (B)(6) 2020 AND THE SUTURE WAS USED. THREE DAYS LATER THE PATIENT EXPERIENCED ERYTHEMA, INFLAMMATION AND PAIN ON THE WOUND. DEBRIDEMENT AND DISINFECTION, RE-SUTURING AND DRESSING WERE GIVEN TO THE PATIENT. BESIDES, SYMPTOMATIC TREATMENT OF PRESCRIBE ORAL MEDICINE WAS GIVEN AS WELL. THE PATIENT'S SYMPTOMS IMPROVED AT THE TIME OF REEXAMINATION TWO DAYS LATER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472270 SILK BRD BLK 15X60CM M2.5 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. PM3BB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention