BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNASPRAY ELECTRODE SOLUTION AND SKIN PREP

    MDR report key: 18749602 · Received February 21, 2024

    Report

    Report Number
    2212018-2024-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    January 18, 2024
    Report Date
    March 28, 2024
    Manufacturer
    PARKER LABORATORIES INC
    Product Code
    JOT
    PMA / PMN Number
    K780973
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PARKER HAS REVIEWED THE DETAILS OF THE COMPLAINT WITH THE INITIAL REPORTER TO VERIFY THAT WE HAVE ALL INFORMATION AVAILABLE. COMPLAINT FILES WERE REVIEWED AND THERE HAVE BEEN NO RELATED COMPLAINTS. PARKER LABS IS AWAITING SAMPLE RETURN FOR INVESTIGATION. SINCE NO LOT# IS AVAILABLE PARKER IS NOT ABLE TO INVESTIGATE RETAINS/BATCH RECORDS. PLEASE NOTE THAT THE PRODUCT CODE IS GYB. HOWEVER, IT WAS NOT AN OPTION ON THE LIST SO JOT WAS SELECTED.

    Additional Manufacturer Narrative · 0

    CUSTOMER WILL NOT BE SHIPPING THE PRODUCT BACK TO PARKER LABS.

    Description of Event or Problem · 0

    CLINICIAN BROKE OUT IN HIVES ON HER FACE (ESPECIALLY AROUND HER EYES) THE REACTION THEN MOVED DOWN THE TRUNK OF THE BODY. TOOK ORAL BENADRYL. THE REACTION THEN PROGRESSED TO A HOARSE VOICE AND LIPS STARTED SWELLING. WENT TO THE ER AT THAT POINT. PULSE AND BLOOD PRESSURE WERE BOTH ELEVATED AT THE ER. WAS GIVEN IV SOLUMEDROL, IV PEPCID, FLUIDS AND IV BENADRYL. WAS SENT HOME FROM THE ER WITH PRESCRIPTIONS FOR PREDNISONE, PEPCID AND AN EPI PEN. 2024-01-18 THE BOTTLE OF SPRAY SOLUTION FELL OVER, BROKE AND LEAKED ALL OVER THE TOP OF A CART. CLINICIAN CLEANED UP A LARGE VOLUME OF THE SPILL WITH PAPER TOWELS (WAS NOT WEARING GLOVES) AND WASHED HER HANDS. SHE HAD NOT EVER USED OR TOUCHED THIS PRODUCT PRIOR TO CLEANING UP THE SPILL. (B)(6) 2024 WITHIN 1.5 - 2 HOURS OF CLEANING UP THE SPILL, SHE BROKE OUT IN HIVES ON HER FACE (ESPECIALLY AROUND HER EYES) THE REACTION THEN MOVED DOWN THE TRUNK THE BODY. (B)(6) 2024 TOOK ORAL BENADRYL. THE REACTION THEN PROGRESSED TO A HOARSE VOICE AND LIPS STARTED SWELLING. WENT TO THE ER AT THAT POINT. PULSE AND BLOOD PRESSURE WERE BOTH ELEVATED AT THE ER. WAS GIVEN IV SOLUMEDROL, IV PEPCID, FLUIDS AND IV BENADRYL. WAS SENT HOME FROM THE ER WITH PRESCRIPTIONS FOR PREDNISONE, PEPCID AND AN EPI PEN. (B)(6) 2024- STILL HAD SOME SWELLING ON EYELIDS. (B)(6) 2024 CONDITION HAD COMPLETELY RESOLVED. (B)(6) 2024 - IN THE PAST COUPLE OF WEEKS, CLINICIAN HAD MULTIPLE EPISODES OF HIVES. SAW AN ALLERGIST (B)(6) 2024 AND HE WANTS HER TO WAIT TWO WEEKS AND THEN DO A PATCH TEST WITH THE SPRAY.

    Description of Event or Problem · 0

    2024-03-06 - CLINICIAN HAD A PATCH TEST WITH THE ELECTRODE SPRAY AND SHE DID NOT REACT TO IT. HER DOCTORS HAVE RULED OUT THE ELECTRODE SPRAY CAUSING AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89534 SIGNASPRAY ELECTRODE SOLUTION AND SKIN PREP SIGNASPRAY ELECTRODE SOLUTION AND SKIN PREP JOT PARKER LABORATORIES INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention