BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QC HEMOSTATIC DRESSING, 4X4, 10X

    MDR report key: 15828378 · Received November 18, 2022

    Report

    Report Number
    3011137372-2022-00214
    Event Type
    Injury
    Date Received
    November 18, 2022
    Date of Event
    July 28, 2022
    Report Date
    October 28, 2022
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    UDI-DI
    00841495104596
    PMA / PMN Number
    K123387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE IS NOT EXPECTED FOR RETURN TO BE INVESTIGATED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    (B)(4). NO PRODUCT RETURNED TO EVALUATE. VISUAL , DIMENSIONAL, AND FUNCTIONAL EXAMINATION WOULD HAVE NO IMPACT TO THE PRODUCT BASED UPON NOTED COMPLAINT STATEMENT. NO LOT NUMBER WAS PROVIDED THEREFORE A REVIEW OF THE DHR (DEVICE HISTORY RECORD) COULD NOT BE PERFORMED. REVIEW OF THE IFU HAS DETERMINED THE FOLLOWING WARNING HAS BEEN PRESENT SINCE PRODUCT LAUNCH: WARNINGS: PRODUCT IS NOT ABSORBABLE AND MUST BE REMOVED FROM WOUND PRIOR TO WOUND CLOSURE. THE USER DID NOT FOLLOW INSTRUCTIONS AND WARNINGS LISTED IN IFU. THIS COMPLAINT IS THE RESULT OF USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 4X4 QUIK CLOT WAS LEFT BEHIND IN PATIENT AND CLOSED DURING AN ORTHO SPINE CASE ON (B)(6) 2022. ADDITIONAL INFORMATION: IT WAS REPORTED THAT 2-3 WEEKS AFTER THE INITIAL SURGERY THE PATIENT HAD A POST-OP VISIT AND IT WAS DISCOVERED THAT THE SPONGE HAD BEEN LEFT INSIDE THE PATIENT. NO PHYSICAL SIGNS OR SYMPTOMS WERE DESCRIBED IN THIS REPORT. THE PATIENT HAD AN OVERNIGHT HOSPITAL STAY AFTER THE SURGERY TO REMOVE THE SPONGE. THE PATIENT'S CURRENT CONDITION POST-OP WAS REPORTED AS "NO ISSUES HAVE BEEN REPORTED" AND IT IS UNKNOWN IF ANY ANTIBIOTICS OR OTHER TREATMENT WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 4X4 QUIK CLOT WAS LEFT BEHIND IN PATIENT AND CLOSED DURING AN ORTHO SPINE CASE ON 28JUL2022. ADDITIONAL INFORMATION: IT WAS REPORTED THAT 2-3 WEEKS AFTER THE INITIAL SURGERY THE PATIENT HAD A POST-OP VISIT AND IT WAS DISCOVERED THAT THE SPONGE HAD BEEN LEFT INSIDE THE PATIENT. NO PHYSICAL SIGNS OR SYMPTOMS WERE DESCRIBED IN THIS REPORT. THE PATIENT HAD AN OVERNIGHT HOSPITAL STAY AFTER THE SURGERY TO REMOVE THE SPONGE. THE PATIENT'S CURRENT CONDITION POST-OP WAS REPORTED AS "NO ISSUES HAVE BEEN REPORTED" AND IT IS UNKNOWN IF ANY ANTIBIOTICS OR OTHER TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321891 QC HEMOSTATIC DRESSING, 4X4, 10X DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC 0459 NA 00841495104596

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| R| O NONE REPORTED| NONE REPORTED