BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABLE BASE

    MDR report key: 5077969 · Received September 11, 2015

    Report

    Report Number
    8020045-2015-00058
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    April 29, 2015
    Report Date
    September 10, 2015
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    PMA / PMN Number
    024247
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR DISTRIBUTOR RECEIVED A TOTAL OF (B)(4) COMPLAINTS FROM THE SAME SUB-DISTRIBUTOR. THEY INFORMED US THESE HAD BEEN COLLECTED OVER A PERIOD OF TIME BUT COMPLAINED TOGETHER. WE CONSIDER FOUR OF THEM AS (POTENTIALLY) REPORTABLE AND ARE FILING SEPARATE MDRS FOR EACH ONE OF THESE. RETAINED SAMPLES OF THE SAME LOT WERE INSPECTED VISUALLY, MECHANICALLY AND FOR THEIR PH. IN ADDITION, FOUR ELECTRODES WERE APPLIED ON A VOLUNTEER FOR SIX HOURS. NO REACTION OR DEVIATION COULD BE OBSERVED. DESPITE OF REPEATED REQUESTS FROM US, THE INITIAL REPORTER WAS NOT ABLE TO SUPPLY US WITH MORE INFO ON THE TREATMENT OF THE INJURY AFTERWARDS. NO CONCLUSION REGARDING THE CAUSE OF THE SKIN REACTION CAN BE DRAWN. IT WAS NOT POSSIBLE TO RECEIVE ANY FURTHER INFO DESPITE REPEATED REQUESTS. NO CONCLUSION REGARDING THE CAUSE OF THE INCIDENT CAN BE DRAWN. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    OUR DISTRIBUTOR RECEIVED A TOTAL OF NINE COMPLAINTS FROM THE SAME SUB-DISTRIBUTOR. THEY INFORMED US THESE HAD BEEN COLLECTED OVER A PERIOD OF TIME BUT COMPLAINED TOGETHER. WE CONSIDER FOUR OF THEM AS (POTENTIALLY) REPORTABLE AND ARE FILING SEPARATE MDRS FOR EACH ONE OF THESE. RETAINED SAMPLES OF THE SAME LOT WERE INSPECTED VISUALLY, MECHANICALLY AND FOR THEIR PH. IN ADDITION, FOUR ELECTRODES WERE APPLIED ON A VOLUNTEER FOR SIX HOURS. NO REACTION OR DEVIATION COULD BE OBSERVED. DESPITE OF REPEATED REQUESTS FROM US THE INITIAL REPORTER WAS NOT ABLE TO SUPPLY US WITH MORE INFO ON THE TREATMENT OF THE INJURY AFTERWARDS. NO CONCLUSION REGARDING THE CAUSE OF THE SKIN REACTION CAN BE DRAWN. WE WILL PROVIDE A FOLLOW UP REPORT WHEN WE WILL RECEIVE ADDITIONAL INFO.

    Description of Event or Problem · 1

    ON (B)(6) 2015, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES (MODEL T60). A 30 DAYS MONITORING WAS PERFORMED. THE PT'S SKIN TYPE WAS DESCRIBED AT NORMAL, NO HAIR. THE SKIN WAS DESCRIBED AS CLEAN, NOT SHAVEN, NOT DISINFECTED, NO OINTMENT WAS USED AND DRIED. THE GENERAL STATE OF THE PT WAS DESCRIBED AS NORMAL. WE HAVE BEEN INFORMED THAT THE MEDICAL HISTORY OF THE PT ("THAT COULD CAUSE OR CONTRIBUTE TO SKIN REACTIONS") WAS DESCRIBED AS VERY SENSITIVE. FOUR ELECTRODES WERE APPLIED TO THE CHEST AREA. ATER 8 HOURS THE PT DISCONNECTED THE ELECTRODES BECAUSE SHE HAD DEVELOPED A RASH. UPON REMOVING THE ELECTRODES SHE DISCOVERED "WHELPS, BROKEN SKIN, BURNING, BLEEDING, ITCHING AND PUSS "UNDERNEATH AND AROUND THE OUTSIDE OF THE ELECTRODES". NO FURTHER INFO ON THE SKIN TREATMENT AFTERWARDS HAVE BEEN REPORTED TO THE DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES (MODEL T60). A 30 DAYS MONITORING WAS PERFORMED. THE PT'S SKIN TYPE WAS DESCRIBED AS NORMAL, NO HAIR. THE SKIN WAS DESCRIBED AS CLEAN, NOT SHAVEN, NOT DISINFECTED, NO OINTMENT WAS USED AND DRIED. THE GENERAL STATE OF THE PT WAS DESCRIBED AS NORMAL. WE HAVE BEEN INFORMED THAT THE MEDICAL HISTORY OFT EH PT ("THAT COULD CAUSE OR CONTRIBUTE TO SKIN REACTIONS") WAS DESCRIBED AS VERY SENSITIVE. FOUR ELECTRODES WERE APPLIED TO THE CHEST AREA. AFTER 8 HOURS THE PT DISCONNECTED THE ELECTRODES BECAUSE SHE HAD DEVELOPED A RASH. UPON REMOVING THE ELECTRODES SHE DISCOVERED "WHELPS, BROKEN SKIN, BURNING, BLEEDING, ITCHING AND PUSS" "UNDERNEATH AND AROUND THE OUTSIDE OF THE ELECTRODES". NO FURTHER INFO ON THE SKIN TREATMENT AFTERWARDS HAVE BEEN REPORTED TO THE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603159 STABLE BASE ECG ELECTRODE DRX LEONHARD LANG GMBH T60 41030-0157

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other