BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABRA ABDOMINAL WALL CLOSURE SET

    MDR report key: 10689685 · Received October 16, 2020

    Report

    Report Number
    8022032-2020-00004
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    September 18, 2020
    Report Date
    October 16, 2020
    Manufacturer
    SOUTHMEDIC INC.
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE COMPLAINT DESCRIPTION, IT APPEARS THAT THERE WAS PATIENT BOWEL INJURY THAT WAS POSSIBLY ATTRIBUTED TO THE ABRA ABDOMINAL DEVICE IN CONJUNCTION WITH ANOTHER DEVICE, KCI'S ABTHERA. HOWEVER, THE ABRA ABDOMINAL DEVICE PERFORMED AS EXPECTED AND THERE WAS NO PRODUCT MALFUNCTION. THE BOWEL INJURY WAS LIKELY OFF LABEL USE DUE TO USER ERROR, BUT BECAUSE INJURY OCCURRED, SOUTHMEDIC HAS CHOSEN TO REPORT THE EVENT. THE PHYSICIAN BELIEVES THAT THE SUCTION FORCES FROM THE WOUND VAC HAD FUNNELED THROUGH THE ELASTOMER RETAINER CAUSING IT TO SUCTION THE SMALL INTESTINE, WHICH OVER TIME MAY HAVE CAUSED THE BOWEL LEAK. THE INSTRUCTIONS FOR USE FOR THE ABTHERA DEVICE DETAILS THE NEED TO USE A VISCERAL PROTECTIVE LAYER, COVERING ALL EXPOSED VISCERA DURING USE. THE ABRA ABDOMINAL INSTRUCTIONS FOR USE DETAIL THE NEED TO USE THE SOUTHMEDIC SURGICAL RETAINER TO PROVIDE VISCERAL PROTECTION. THE ABRA ABDOMINAL IFU ALSO INCLUDES THE INSTRUCTION TO TRIM THE ELASTOMER RETAINER TO MATCH THE WOUND LENGTH, WHICH WOULD ENSURE THAT THE ELASTOMER RETAINER WOULD NOT OVERHANG BEYOND THE SURGICAL RETAINER, AS THE SURGICAL RETAINER IS INTENDED TO EXTEND BEYOND THE INSERTION POINTS. THE SURGICAL RETAINER WOULD ACT AS A BARRIER BETWEEN THE ELASTOMER RETAINER AND ABDOMINAL CONTENTS.

    Description of Event or Problem · 1

    A SURGEON AT THE FACILITY REPORTED SEEING A LAYER OF CONGEALED FLUID ALONG THE INNER EDGE OF THE SURGICAL RETAINER AND INSIDE OF THE ELASTOMER RETAINER IN AN ABRA ABDOMINAL PATIENT AT THE TIME OF CLOSURE ON (B)(6). THE SURGEON EXPRESSED CONCERN THAT THE GUNKY MATERIAL MIGHT POSE A RISK FOR CONTAMINATION AND WANTED TO HAVE IT CULTURED. NEVERTHELESS, THE SURGEON CHOSE TO CLOSE THE PATIENT AT THE TIME SO THEY MAY NOT HAVE BEEN OVERLY CONCERNED ABOUT A CONTAMINATED BELLY. IT SHOULD ALSO BE NOTED THAT THE SURGEON WAS NOT THE PATIENT'S PRIMARY SURGEON, THEY DID NOT INSTALL ABRA NOR HAD THEY TREATED THIS PATIENT PRIOR TO THIS MOMENT, BUT INSTEAD THEY WERE THE SURGEON IN THE ICU COVERING THE PLANNED WOUND VAC CHANGE THAT DAY. ADDITIONAL INFORMATION FROM THE SURGEON WHO INSTALLED THE ABRA DEVICE IN THIS CASE, STATED THAT THE CASE WAS FOR A MALE PATIENT, (B)(6) YEARS OF AGE WHO HAD ACUTE ALCOHOLIC PANCREATITIS AND A DECOMPRESSIVE LAPAROTOMY ON (B)(6) 2020. THE ABRA WAS INSTALLED BY THE FIRST SURGEON ON (B)(6) 2020. THE ABRA WAS REMOVED BY THE SECOND SURGEON ON (B)(6) 2020 WITH SMALL BOWEL RESECTION AND REPAIR FOR LEAK. THERE WAS A SUBSEQUENT TAKE BACK FOR WASHOUT AND PARTIAL ABDOMINAL CLOSURE ON (B)(6) AND (B)(6). A KCI WITH STANDARD NEGATIVE ABDOMINAL WOUND VAC THERAPY (NOT SURE ABOUT EXACT LEVELS). THE SMALL BOWEL INJURY APPEARED TO BE SECONDARY TO A LOOP OF SMALL BOWEL COMING UP FROM AROUND THE ABDOMINAL PROTECTOR AND GETTING SUCTIONED INTO THE END OF THE TUBE THAT HOLDS THE ELASTOMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155853 ABRA ABDOMINAL WALL CLOSURE SET ABDOMINAL WALL CLOSURE SET LRO SOUTHMEDIC INC. CWK08 W69073

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R