BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 10659839 · Received October 9, 2020

    Report

    Report Number
    2210968-2020-07853
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    September 17, 2020
    Report Date
    September 27, 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: 11/24/2020. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PLEASE CLARIFY A DATE AND NAME OF INDEX SURGICAL PROCEDURE? DEBRIDEMENT AND SUTURE OF OPEN WOUND OF RIGHT LEG ON (B)(6) 2020. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: THE PATIENT DEMOGRAPHIC INFO: WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE? PRODUCT CODE AND LOT NUMBER? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WERE THERE ANY PRE-EXISTING SIGNS / SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? 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? OTHER RELEVANT PATIENT COMORBIDITIES / CONCOMITANT MEDICATIONS? WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WERE THERE ALL SYMPTOMS RESOLVED AFTER RE-SUTURING? 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). 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 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. PLEASE CLARIFY A DATE AND NAME OF INDEX SURGICAL PROCEDURE? PRODUCT CODE AND LOT NUMBER? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? 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? OTHER RELEVANT PATIENT COMORBIDITIES/CONCOMITANT MEDICATIONS? WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WERE THERE ALL SYMPTOMS RESOLVED AFTER RE-SUTURING?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN DEBRIDEMENT AND SUTURE OF OPEN WOUND OF RIGHT LEG PROCEDURE ON UNKNOWN DATE AND THE SUTURE WAS USED TO CLOSE THE WOUND. NINE DAYS LATER, POOR WOUND HEALING AND LOCAL INFECTION WERE FOUND. THE WOUND WAS OPENED AND WASHED CONTINUOUSLY WITH USD DRAINAGE TUBE. CEFUROXIME WAS INJECTED INTRAVENOUSLY. THE PATIENT WAS OBSERVED CLOSELY AND RE-SUTURED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123607 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention