BEUDAMED
    FDA Adverse Event Summary report: N

    RESPIRONICS VITAL SENSE CAPSULE SENSOR

    MDR report key: 3010681 · Received March 13, 2013

    Report

    Report Number
    MW5029371
    Date Received
    March 13, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 28, 2013
    Product Code
    GWK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RESEARCH PARTICIPANT INGESTED A VITALSENSE CAPSULE SENSOR, CORE TEMPERATURE CAPSULE, MANUFACTURED BY RESPIRONICS AT 0845. PARTICIPANT STATED THAT CAPSULE BECAME "STUCK" ON LEFT UPPER LIP BEFORE SWALLOWING WITH WATER. CONSUMED BREAKFAST AND ROUTINE HOME MEDICATIONS (LISINOPRIL/HCTZ) AT 1000. NOTICED LEFT UPPER LIP TINGLING 30 MINUTE LATER. WAITED TO REPORT TO STAFF UNTIL APPROX 1330 OF LEFT UPPER LIP TINGLING AND SWELLING. REPORTED ONE EPISODE SIMILAR IN PAST AS REACTION TO IODINE. UPON EXAM NOTED SLIGHT LEFT UPPER LIP EDEMA. DENIED ADD'L SIGNS OR SYMPTOMS. PARTICIPANT GIVEN DIPHENHYDRAMINE 25 MG PO. LOCALIZED LIP SWELLING PROGRESSED TO ENTIRE LEFT LATERAL LIP, WITHOUT ADD'L SIGNS AND SYMPTOMS. PARTICIPANT GIVEN 2ND DOSE OF DIPHENHYDRAMINE 25 MG PO. LIP EDEMA PROGRESSED OVER NEXT 2 HOURS AND REFERRED TO ER FOR FURTHER EVAL AND TREATMENT. TREATED WITH IV DECADRON, IV FAMOTIDINE AND DIPHENHYDRAMINE IN THE ER, AND ADMITTED FOR OBSERVATION (< 23 HOUR STAY). WAS GIVEN IV FLUIDS OF NORMAL SALINE FOR HYDRATION. HOSPITAL STAY WITHOUT COMPLICATIONS. HOSPITAL DISCHARGE DIAGNOSIS: ANGIOEDEMA LIKELY DUE TO ACE INHIBITORS. LISINOPRIL DISCONTINUED. DISCHARGED HOME ON HYDROCHLORTHIAZIDE FOR HYPERTENSION MANAGEMENT. RESEARCH COORDINATOR FOLLOWED UP WITH PARTICIPANT ON (B)(6) 2013 VIA PHONE WITH REPORTED COMPLETE RESOLUTION OF SIGNS AND SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106355 RESPIRONICS VITAL SENSE CAPSULE SENSOR CORE TEMPERATURE SENSOR/CAPSULE GWK 500-0100-02 314250

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization