BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM

    MDR report key: 19584903 · Received June 21, 2024

    Report

    Report Number
    1416980-2024-03110
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 7, 2024
    Report Date
    July 23, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MCN
    UDI-DI
    05413765588211
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT ROBOT-ASSISTED LOW ANTERIOR RECTAL RESECTION WHEREIN SEPRAFILM WAS APPLIED. THE PROCEDURE OCCURRED TWENTY-TWO DAYS PRIOR TO THE RECEIPT OF THIS REPORT. THE FOLLOWING DAY, THE PATIENT COMPLAINED OF ABDOMINAL AND WOUND PAIN. THE PATIENT WAS PRESCRIBED TYLENOL FOR THE PAIN. FOUR DAYS LATER, A CT SCAN WAS PERFORMED DUE TO A SUSPICION OF POST-SURGICAL SMALL INTESTINAL PERFORATION; HOWEVER, AN ABSCESS WAS FOUND. THE FOLLOWING DAY, A DRAINAGE TUBE WAS INSERTED. THREE DAYS LATER, BLOOD CULTURES WERE TAKEN WHICH SHOWED BACILLUS SUBTILIS AND BACTEROIDES CACCAE. THE PATIENT WAS STARTED ON UNACIN, PISULSIN, SULVACILLIN (ABPC/ SBT). TWO DAYS AFTER THE ANTIBIOTIC WAS CHANGED TO PIPERACILLIN TAZOBACTAM. SIX DAYS AFTER THAT, AN UNSPECIFIED CONTRAST TEST WAS PERFORMED AND FOUND SUTURE FAILURE. A WEEK LATER, ANOTHER CT SCAN WAS PERFORMED AND FOUND MILD ABSCESS IMPROVEMENT; HOWEVER, THE PATIENT WAS STILL HOSPITALIZED. THE FOLLOWING DAY THE ANTIBIOTIC WAS CHANGED BACK TO ABPC/ SBT. TWO WEEKS LATER, THE DRAIN TUBE WAS CLAMPED. TWO DAYS AFTER THAT, NO FEVER WAS NOTED, AND THE DRAIN TUBE WAS REMOVED. FOUR DAYS LATER, THE ANTIBIOTIC WAS DISCONTINUED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE ABSCESS WAS DEEMED IMPROVED, AND THE PATIENT HAD RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184524 SEPRAFILM BARRIER, ABSORABLE, ADHESION MCN BAXTER HEALTHCARE CORPORATION NA CBYSEP049 05413765588211

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| R