BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESICE ICEROD PROSTATE KIT

    MDR report key: 2031943 · Received July 8, 2010

    Report

    Report Number
    9616793-2010-00008
    Event Type
    Injury
    Date Received
    July 8, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SKIN BURN IS A SERIOUS, BUT KNOWN AND INHERENT RISK OF CRYOTHERAPY. THE OCCURRENCE RATE OF A BURN IS RARE. THERE ARE SEVERAL POTENTIAL MITIGATION THAT A PHYSICIAN CAN IMPLEMENT TO TRY TO AVOID A BURN. APPLYING GAUZE AND WARM SALINE TO THE SKIN DURING TREATMENT IS THE MOST COMMON AND EFFECTIVE MEANS OF PREVENTING A BURN. OTHER IMPORTANT MITIGATIONS INVOLVE SPACING OF THE NEEDLES. NEEDLES SHOULD BE SPACED GREATER THAN 1 CM APART TO REDUCE ANY EFFECT THE NEEDLES MAY HAVE AT THE SKIN SURFACE. ADDITIONALLY, NEEDLE LENGTH AND ICE BALL LENGTH SHOULD BE EVALUATED TO ENSURE THE ACTIVE AREA (ICE BALL) OF THE NEEDLE IS BELOW THE SKIN PLANE. IF A PT STILL DEVELOPS A SKIN BURN, IT IS LIKELY THAT THEY WILL REQUIRE MEDICAL TREATMENT. THIS TREATMENT MAY INCLUDE HOSPITALIZATION AND/OR POSSIBLY A SKIN GRAFT TO TREAT THE BURN.

    Description of Event or Problem · 1

    DURING THE F/U VISIT, THE PT PRESENTED WITH BURNS. THE DOCTOR NOTICED THAT THE PT HAD 4 SKIN BURNS AT THE CRYONEEDLE SITE (PERINEUM). THE DOCTOR IS TREATING THE WOUNDS AS OUTPATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESICE ICEROD PROSTATE KIT CRYOSURGICAL UNIT GEH GALIL MEDICAL LTD. FPRPR4570

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention