BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 12906643 · Received December 1, 2021

    Report

    Report Number
    2210968-2021-12207
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    October 12, 2021
    Report Date
    December 1, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    UDI-DI
    10705031132993
    PMA / PMN Number
    K093845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 01/17/2022. 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, 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 PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE NOT GIVEN DETAILS BY HOSPITAL. NAME OF INITIAL SURGICAL PROCEDURE VENTRAL HERNIA. THE DIAGNOSIS AND INDICATION FOR THE INITIAL SURGICAL PROCEDURE? HERNIA. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? NO. PATIENT SYMPTOMS MANIFESTATIONS (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL REACTION)? NOT GIVEN DETAILS BY HOSPITAL. DATE - TIME OF ONSET OF INFECTION FROM THE SURGICAL PROCEDURE? AFTER SURGERY. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? NO. DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? DETAILS NOT GIVEN BY HOSPITAL. WERE CULTURES PERFORMED? RESULTS? DETAILS NOT GIVEN BY HOSPITAL. WHAT MEDICAL INTERVENTION WAS PERFORMED? RESULTS? DURING TRACKER FIXATION STRAP25 FIRED 3 TIMES ONLY BUT 4TH TIME ONWARDS, PRODUCT GOT LOCKED OR DID NOT FIRE. IF APPLICABLE, WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION PRODUCT NOT RETURNED BY HOSPITAL, AS HOSPITAL KEPT THIS IMPACTED STRAP 25 PRODUCT. WHAT IS THE PATIENT'S CURRENT STATUS? PATIENT CONDITION IS GOOD AS PER INFORMATION RECEIVED FROM HOSPITAL DOCTORS. DOES THE SURGEON ALLEGE A DEFICIENCY OF THE DEVICE THAT LED TO THE POST-OP COMPLICATION OF INFECTION? NO PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 01/17/2022. CORRECTED INFORMATION: B1, B2, H1: ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THEREFORE, THIS MEDWATCH REPORT WILL BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCE WERE IDENTIFIED. EVALUATION: AFTER VISUAL INSPECTION OF THE IMAGES, A DEVICE WAS OBSERVED WITH THE INDICATOR COMPLETELY ORANGE. THIS MEANS THAT THE DEVICE WAS FULLY DISPENSED. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE REPORTED COMPLAINT SINCE THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. ADDITIONAL MONITORING OF COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS IS CARRIED OUT THROUGH COMPLAINT TRENDS AS PART OF POST-MARKET SURVEILLANCE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE PATIENT TREATMENT ALTERED IN ANYWAY DUE TO THE PROLONGED SURGERY TIME? IF YES, PLEASE EXPLAIN. YES. PATIENT HAS FEVER & SHIFTED TO ICU FOR TWO DAY WITH HIGHER ANTIBIOTICS. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED TO TREAT THE FEVER (RE-OPERATION; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? PATIENT KEPT ON ANTIBIOTICS FOR TWO DAYS. ALSO KEPT IN ICU FOR TWO DAYS. WHAT IS THE MOST CURRENT PATIENT HEALTH STATUS AND CONDITION? NOW PATIENT CONDITION IS GOOD AS PER INFORMATION RECEIVED FROM HOSPITAL DOCTORS IN LAST WEEK FRIDAY. 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, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE NAME OF INITIAL SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INITIAL SURGICAL PROCEDURE? OTHER RELEVANT PATIENT HISTORY/ CONCOMITANT MEDICATIONS. PATIENT SYMPTOMS MANIFESTATIONS (LOCATION, SEVERITY, APPEARANCE, SYSTEMIC OR LOCAL REACTION). DATE - TIME OF ONSET OF INFECTION FROM THE SURGICAL PROCEDURE? 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? WERE CULTURES PERFORMED? RESULTS? WHAT MEDICAL INTERVENTION WAS PERFORMED? RESULTS? 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? DOES THE SURGEON ALLEGE A DEFICIENCY OF THE DEVICE THAT LED TO THE POST-OP COMPLICATION OF INFECTION?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2021 AND THE ABSORBABLE STRAP WAS USED. IT WAS REPORTED THAT DURING FIXATION THE DEVICE ONLY FIRED THREE TIMES THEN LOCKED AND DID NOT FIRE AT THE FOURTH TIME AND ONWARDS. IT WAS REPORTED THAT THE SURGERY WAS DELAYED AND CAUSED THE PROCEDURE TO LAST 210 MINUTES. IT WAS REPORTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY FIXATING THE MESH WITH SUTURES INSTEAD OF THE STRAP. IT WAS REPORTED THAT THE PATIENT HAD A FEVER FOR MORE THAN 24 HOURS FROM SURGERY. IT WAS REPORTED THAT THE PATIENT WAS SHIFTED TO THE ICU FOR TWO DAYS WITH HIGHER ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806935 ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. STRAP25 RAMDAR 10705031132993

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R