BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSENTIA MAJ LAPAROTOMY STD PACK

    MDR report key: 21493779 · Received February 28, 2025

    Report

    Report Number
    3014421917-2025-00008
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    January 31, 2025
    Report Date
    April 9, 2025
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    FDE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AMERICAN CONTRACT SYSTEMS, INC. (ACS) KANSAS CITY WHERE COMPLAINT KIT WAS MANUFACTURED HAS NOW CLOSED. MEDICAL ACTION INDUSTRIES IS THE RELABELLER/REPACKAGER OF THE COMPLAINT TOWEL COMPONENT. A PHOTO OR SAMPLE WAS NOT PROVIDED BY THE CUSTOMER. AT THE TIME OF COMPLAINT RECEIPT, NEITHER ACS NOR MEDICAL ACTION INDUSTRIES DID NOT HAVE ANY INVENTORY OF THE TOWEL LOT AVAILABLE FOR FURTHER ANALYSIS. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED; NO ABNORMALITIES WERE FOUND DURING THE PRODUCTION AND INSPECTION PROCESSES AT BOTH ACS KANSAS CITY AND MEDICAL ACTION INDUSTRIES. A 12-MONTH REVIEW OF THE TRENDING DATABASE SHOWS ONE PAST AND TWO RECENT COMPLAINTS FOR THE REPORTED ISSUE OF LINT INVOLVING THIS TOWEL. THE TOWEL LOT HAS SHIPPED TO VARIOUS CUSTOMERS WITH NO ADDITIONAL REPORTS ON THIS LOT. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR EVALUATION. THE TOWEL COMPONENT MANUFACTURED WITHIN THE PACK (731-B4) WAS SUPPLIED BY MEDICAL ACTION INDUSTRIES. A FOLLOW UP REPORT WILL BE SUBMITTED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    END-USER UTILIZED A MAJOR LAPAROTOMY PACK AS WELL AS TWO PACKAGES OF STERILE BLUE OR TOWELS FOR PROCEDURE. THE SURGEON USED BLUE TOWELS TO LINE THE EDGES OF THE INCISION AND PLACED THE BOWEL ON THE TOWELS. IT WAS DISCOVERED LATER THERE WERE SMALL PIECES OF BLUE LINT SEEN ON THE BOWEL OF THE PATIENT. THE PATIENT WAS UNDERGOING AN EXPLORATORY LAPAROTOMY AND SMALL BOWEL RESECTION AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED LINT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030309 ESSENTIA MAJ LAPAROTOMY STD PACK ESSENTIA MAJ LAPAROTOMY STD PACK FDE AMERICAN CONTRACT SYSTEMS, INC. ESLT53 12-7182011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other