BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND* EXCEL

    MDR report key: 19749640 · Received July 16, 2024

    Report

    Report Number
    2210968-2024-07244
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 REQUESTED, AND THE FOLLOWING WAS OBTAINED: THE FOUR FACELIFT THAT WE PERFORMED HAPPENED IN SECOND HALF OF THE YEAR 2020. THEY WERE ALL DONE AT THE AVENUE HOSPITAL (TAH) AND NOT MANY SURGERIES WERE PERFORMED DUE TO COVID LOCKDOWN FOR AWHILE. HOWEVER SOME SUBSEQUENT SURGERIES PERFORMED DIDN¿T SEEM TO GIVE ANY TROUBLE WITH THE SAME 3/0 ETHIBOND SUTURES D9890. I CHECKED ON THE TAH STOCK LEVEL (B)(4) BOXES IN TOTAL ON SHELF ARE OF SAME EXPIRY DATE. 2026-08-31 WITH LOT RKMCSM AND LOT RDMLXD. I COULDN¿T FIND OUT FROM THE HOSPITAL AS TO THE PREVIOUS ORDER OF SAME SUTURES FROM J&J. INTERESTINGLY ALL SAME ISSUES OCCURRED YEARS LATER AFTER SURGERY TO FIND IT¿S WAY TO THE SURFACE. 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 NEW INFO PROVIDED MENTIONS 3/0 ETHIBOND SUTURES D9890 LOT RKMCSM OR LOT RDMLXD. WAS THIS THE PRODUCT USED DURING THE RE-OPERATION IN 2024? *WAS THERE ANY ISSUES WITH D9890 - LOT RKMCSM / LOT RDMLXD? IF YES, PLEASE EXPLAIN. *WAS PRODUCT XTQ0Q LOT UNKNOWN USED DURING THE INITIAL PROCEDURE IN 2020? IF NO, PLEASE EXPLAIN. *WAS MEDICAL OR SURGICAL INTERVENTION REQUIRED FOR PATIENT 3 AND PATIENT 4? IF SO, PLEASE SPECIFY. *FOR ALL PATIENTS, DID THE SUTURE COME TO THE SURFACE (SUTURE EXTRUSION) IN ADDITION TO WOUND DISCHARGE? D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED . 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. UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 DATE AND NAME OF INDEX SURGICAL PROCEDURE? DID THE PATIENT¿S INDEX PROCEDURE OCCUR 24 YEARS AGO IN 2000? 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.)? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? PLEASE PROVIDE THE ONSET DATE/TIME OF THE DISCHARGE FROM THE INITIAL PROCEDURE. DID THE PATIENT HAVE PERSISTENT DISCHARGE FROM THE CHEEK FOR THE PAST 24 YEARS? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? DOES THE PATIENT HAVE A KNOWN ALLERGIC HISTORY TO ANY MEDICAL DEVICES, FOOD AND/OR MEDICATION? WAS ALLERGY TESTING PERFORMED? IF SO, PLEASE DESCRIBE WITH RESULTS. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? LOT NUMBER? ARE THERE ANY PHOTOS AVAILABLE?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT FACELIFT PROCEDURE ON AN UNKNOWN DATE IN 2000 AND SUTURE WAS USED. WITHIN THE LAST 2 WEEKS, THE PATIENT UNDERWENT REOPERATION TO REMOVE A LONG TERM SUTURE THAT HAVE BEEN THE BASIS FOR PERSISTENT DISCHARGE FROM THE CHEEK. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507033 ETHIBOND* EXCEL SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention