BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK BRD BLK 15X60CM M2.0

    MDR report key: 14337837 · Received May 9, 2022

    Report

    Report Number
    2210968-2022-03492
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    April 22, 2022
    Report Date
    June 15, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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. 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. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WERE CULTURES PERFORMED? RESULTS? 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: 6/8/2022. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION: H6. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE: 69 YEARS OLD, FEMALE. NAME OF INDEX SURGICAL PROCEDURE? SKIN INJURY SUTURE. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? THE PATIENT WAS HOSPITALIZED FOR "CHEST SOFT TISSUE INJURY". WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? OPEN. ON WHAT TISSUE WAS THE SUTURE USED? SKIN. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? NORMAL. HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? INTERRUPTED. HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? UNK. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? NO. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? UNK. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? NO. WERE CULTURES PERFORMED? RESULTS? NO. WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? UNK. WHAT IS THE PATIENT'S CURRENT STATUS? THERE WAS NO PATIENT CONSEQUENCES REPORTED (B)(4). DATE SENT TO THE FDA: 6/8/2022. CORRECTED INFORMATION: A2.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 6/15/2022. 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 INFORMATION WAS RECEIVED: AFTER INVESTIGATION, THE FEMALE PATIENT (69-YEAR-OLD) UNDERWENT DEBRIDEMENT AND SUTURING DUE TO "CHEST SOFT TISSUE INJURY" ON (B)(6) 2022 (WITH UNKNOWN SURGICAL SIDE). DURING THE OPERATION, THE SURGEON USED SA84G FOR SKIN TISSUE SUTURE (WITH UNKNOWN SPECIFIC SUTURING METHOD). THE OPERATION WENT SMOOTHLY. ON (B)(6) 2022, THE PATIENT RETURNED TO THE HOSPITAL FOR REEXAMINATION. DURING EXAMINATION OF THE PATIENT'S WOUND, THE DOCTOR FOUND THAT THE SKIN AT THE SUTURING SITE WAS RED AND SWOLLEN (OTHER SYMPTOMS, SIGNS AND EXAMINATION RESULTS WERE UNKNOWN). THE DOCTOR IMMEDIATELY GAVE THE PATIENT IODINE WET COMPRESS OF THE WOUND AND ORAL ADMINISTRATION OF CEPHALEXIN TABLETS FOR ANTI-INFLAMMATORY TREATMENT (WITH UNKNOWN SPECIFIC TREATMENT DOSE FREQUENCY AND OTHER INFORMATION). ON (B)(6) 2022, THE PATIENT RETURNED TO THE HOSPITAL FOR REEXAMINATION. THE SKIN REDNESS AND SWELLING AT THE SUTURE SITE DISAPPEARED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE A PATIENT UNDERWENT A WOUND CLOSURE ON (B)(6) 2022 AND SUTURE WAS USED ON THE WOUND. POST-OP, ON THE SECOND DAY AFTER THE SURGERY, THE PATIENT RETURNED TO THE HOSPITAL FOR REEXAMINATION AND FOUND THAT THE SKIN AT THE SUTURE KNOT WAS RED AND SWOLLEN. IMMEDIATELY GIVEN IODOPHOR WET COMPRESS AND CEPHALEXIN TABLETS TO REDUCE INFLAMMATION. ON THE FOURTH DAY AFTER THE SURGERY, THE PATIENT RETURNED TO THE HOSPITAL FOR REEXAMINATION AND FOUND THAT THE SYMPTOMS OF SKIN REDNESS AND SWELLING AT THE SUTURE KNOT DISAPPEARED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552767 SILK BRD BLK 15X60CM M2.0 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. RB1BA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention