BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIKCLOT CONTROL+ 12X12 PAD

    MDR report key: 11957318 · Received June 8, 2021

    Report

    Report Number
    3004138549-2021-00002
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    February 25, 2021
    Report Date
    June 8, 2021
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    POD
    UDI-DI
    00841495140303
    PMA / PMN Number
    DEN160012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO QUIKCLOT CONTROL+ 12X12 PADS WERE INADVERTENTLY LEFT INSIDE THE PATIENT FOLLOWED SURGERY AND REQUIRED ADDITIONAL SURGERY TO REMOVE. THE INSTRUCTIONS FOR USE (IFU) STATE THE FOLLOWING: CONTRAINDICATIONS: DO NOT LEAVE QUIKCLOT CONTROL+ IN PLACE FOR MORE THAN 48 HOURS. WARNINGS: QUIKCLOT CONTROL+ DRESSING IS NOT ABSORBABLE AND MUST BE REMOVED FROM WOUND PRIOR TO CLOSURE. THIS IS THE FIRST AND ONLY REPORT OF THIS NATURE CONCERNING THE QUIKCLOT CONTROL+ DRESSINGS SINCE THE PRODUCTS WERE INTRODUCED IN 2017. THIS ISOLATED INCIDENT HAS BEEN ATTRIBUTED TO USE OF THE PRODUCT IN A MANNER NOT CONSISTENT WITH THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    Z-MEDICA, LLC RECEIVED A MEDWATCH FORM FROM THE HOSPITAL ON 5/21/2021. THE REPORT ALLEGED THE THERE WERE RETAINED LAPAROTOMY PADS. THE PATIENT HAD EXPLORATORY LAPAROSCOPY FOR A SUSPECTED PERFORATED DESCENDING COLON. THE PATIENT HAD A VAST AMOUNT OF CANCEROUS TISSUE THAT NEED TO BE REMOVED. DURING THE SURGERY THE PATIENT HAD TOTAL ABDOMINAL COLECTOMY, OMENECTOMY, APPENDECTOMY, BSO, HYSTERECTOMY, AND AN END ILEOSTOMY CREATED ON (B)(6) 2021. QUIKCLOT CONTROL+ DRESSINGS WERE PLACED DEEP IN THE PELVIS TO HELP WITH HEMOSTASIS. THE HOSPITAL REPORT THAT ALL COUNTS WERE CORRECT AT THE END OF THE CASE. THE PATIENT HAD A DELAYED RETURN OF BOWEL FUNCTION AND A CT WAS PERFORMED ON (B)(6) 2021. WHICH SHOWED RETAINED LAP PADS. THE PATIENT WAS TAKEN INTO SURGERY ON (B)(6) 2021 FOR REMOVAL OF THE FOREIGN OBJECTS. ONE LAP SPONGE WAS FOUND IN THE PELVIS AND THE OTHER IN THE RIGHT PARACOLIC GUTTER. THE PATIENT HAD AN UNEVENTFUL SURGERY AND WAS DISCHARGED ON (B)(6) 2021. THE CUSTOMER "OPINED THAT THE X-RAY DETECTABLE ON THE LABEL WAS NOT PROMINENT AND STAFF MAY THINK SPONGES DO NOT NEED TO BE COUNTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850202 QUIKCLOT CONTROL+ 12X12 PAD 12X12 LAP SPONGE POD Z-MEDICA, LLC 4030 10749 00841495140303

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention