BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBL PACKAGE, BASIC ASSEMBLY IN CRATE

    MDR report key: 1403202 · Received June 12, 2009

    Report

    Report Number
    2031963-2009-00014
    Event Type
    Injury
    Date Received
    June 12, 2009
    Date of Event
    May 13, 2009
    Report Date
    May 15, 2009
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL ATTEMPT TO COLLECT PT INFORMATION (AGE, WEIGHT, SEX, IDENTIFIERS) HAS BEEN MADE. FURTHER ATTEMPTS WILL BE MADE TO COLLECT THIS INFORMATION. OUTCOMES ATTRIBUTED TO ADVERSE EVENT IS UNK AT THIS POINT. FURTHER ATTEMPTS WILL BE MADE TO COLLECT THIS INFORMATION. FURTHER ATTEMPTS WILL BE MADE TO COLLECT THIS INFORMATION. THE MENTIONED LATCH OF THE SURGICAL TABLE WAS "STICKING" MOST LIKELY DUE TO INSUFFICIENT SERVICING. ACCORDING TO THE ACCOUNT, THE PERSON WHO WAS REMOVING THE ATTACHMENT FROM THE TABLE BEGAN JIGGLING IT. WHEN THE ATTACHMENT WAS FREED, THE PERSON WAS CAUGHT OFF GUARD BY THE WEIGHT OF THE ATTACHMENT, COULD NOT MAINTAIN THEIR GRIP AND DROPPED THE ATTACHMENT ON THE DOCTOR'S FOOT. FURTHER INFORMATION ABOUT THE PT IS UNK AT THIS POINT. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE INITIAL RPTR THAT THE LATCH OF THE SURGICAL TABLE, ATTACHING TO THE BOTTOM END ON THE RIGHT HAND SIDE OF THE TABLE, WAS "STICKING". PER THE INITIAL RPTR, THE BOTTOM END OF THE TABLE FELL OFF AND LANDED ON THE DOCTOR'S FOOT, CUTTING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBL PACKAGE, BASIC ASSEMBLY IN CRATE FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK