BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABTHERA¿ SENSAT.R.A.C.¿ OPEN ABDOMEN DRESSING

    MDR report key: 17510098 · Received August 11, 2023

    Report

    Report Number
    3009897021-2023-00059
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    December 13, 2022
    Report Date
    August 11, 2023
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    PMA / PMN Number
    K090489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E1 NAME AND ADDRESS, AND SECTION G2 REPORT SOURCE: ABTHERA¿ SENSAT.R.A.C.¿ OPEN ABDOMEN DRESSING WAS ALLEGEDLY INITIALLY PLACED AT A FACILITY IN (B)(6). HOWEVER, THE INITIAL REPORTER'S DETAILS LISTED ARE FROM THE UNITED STATES AS THIS IS WHERE THE ALLEGED RETAINED FOAM WAS IDENTIFIED. THEREFORE, "FOREIGN" WAS NOT CHECKED. BASED ON INFORMATION PROVIDED, KCI CANNOT DETERMINE WHEN THE FOREIGN BODY ALLEGED TO BE THE ABTHERA¿ SENSAT.R.A.C.¿ OPEN ABDOMEN DRESSING WAS PLACED IN THE WOUND. THE FOREIGN MATERIAL WAS NOT RETURNED TO KCI FOR IDENTIFICATION; THEREFORE, KCI IS UNABLE TO CONFIRM ITS IDENTITY. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE FOR ADDITIONAL CLINICAL AND DEVICE INFORMATION. CLINICAL RECORDS INDICATED THE SPONGES WERE PURPOSELY LEFT IN SUBCUTANEOUS TISSUE; THEREFORE, THIS EVENT IS BEING REPORTED DUE TO POTENTIAL USE ERROR. DEVICE LABELING, AVAILABLE IN PRINT, STATES: DRESSING REMOVAL: THE DRESSING COMPONENTS ARE NOT BIOABSORBABLE. ALWAYS REMOVE ALL DRESSING COMPONENTS FROM THE ABDOMEN AT EVERY DRESSING CHANGE. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A KINETIC CONCEPTS, INC. PRODUCT MALFUNCTIONED, IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE FOLLOWING INFORMATION WAS FOUND DURING REVIEW OF CLINICAL RECORDS: THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY ON (B)(6) 2022 WHILE VACATIONING IN (B)(6). HE DEVELOPED ABDOMINAL WALL INFECTION, SEEN ON CT WITH GAST-CONTAINING COLLECTION MEASURING 10.2 X 3.3 X 5.7. A PIGTAIL DRAIN WAS PLACED. HE HAS BEEN FOLLOWED BY INFECTIOUS DISEASE AND IS NOW ON MINOCYCLINE AND AUGMENTIN THERAPY. ADDITIONAL CT IMAGING SHOWED CONCERN FOR RETAINED LAP PAD. AFTER REVIEW OF HIS SURGICAL RECORDS FROM THE HOSPITAL IN (B)(6), PATIENT STATES THAT SPONGES WERE PURPOSELY LEFT IN SUBCUTANEOUS TISSUE. ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY AND A PIECE OF FOREIGN MATERIAL ALLEGED TO BE ABTHERA¿ SENSAT.R.A.C.¿ OPEN ABDOMEN DRESSING WAS IDENTIFIED WITHIN THE PATIENT'S ABDOMEN. NO ADDITIONAL INFORMATION WAS PROVIDED. THE ABTHERA¿ SENSAT.R.A.C.¿ OPEN ABDOMEN DRESSING LOT NUMBER WAS NOT PROVIDED, AND THE PRODUCT WAS NOT RETURNED; THEREFORE, A DEVICE HISTORY RECORD REVIEW AND DEVICE EVALUATION COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233317 ABTHERA¿ SENSAT.R.A.C.¿ OPEN ABDOMEN DRESSING OMP OMP KINETIC CONCEPTS, INC. VACDSP NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H