BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNAPRODE

    MDR report key: 7360871 · Received March 22, 2018

    Report

    Report Number
    8020045-2018-00002
    Event Type
    Injury
    Date Received
    March 22, 2018
    Report Date
    April 12, 2018
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    PMA / PMN Number
    K023503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE SAME LOT NUMBER WERE INSPECTED VISUALLY AND MECHANICALY. IN ADDITION, TWO ELECTRODES WERE APPLIED ON A VOLUNTEER FOR SIX HOURS. NO REACTION OR DEVIATION COULD BE OBSERVED. THE RETAINED SAMPLES WERE WITHIN SPECIFICATION. IT IS UNCLEAR WHETER THE SKIN REACTION WAS CAUSED BY THE ECG ELECTRODES OR BY THE USAGE OF THE REMOIS COAT SPRAY (INTERACTION WITH ELECTRODE COMPONENTS OR INSUFFICIENTLY DRIED SPRAY COAT). IT IS ALSO UNCLEAR WHETER THE SKIN REACTIONS HAD TO BE TREATED. IT WAS NOT POSSIBLE TO RECEIVE THIS INFORMATION DESPITE REPEATED REQUESTS SO FAR. WE RECEIVED AN UPDATE DATED 09TH APRIL. THE DISTRIBUTOR SPECIFIED: "UNFORTUNATELY, WE MAY NOT BE ABLE TO HEAR FROM [THE] HOSPITAL BECAUSE THE PERSON IN CHARGE OF THE HOSPITAL RETIRED." WE THEREFORE HAVE NOT ENOUGH INFORMATION TO DECIDE WHETHER THESE EVENTS CONSTITUTE REPORTABLE INCIDENTS. AS NO FURTHER INFORMATION WILL BECOME AVAILABLE ON THE INCIDENTS WE CLOSE THE REPORT.

    Description of Event or Problem · 0

    ON (B)(6)2018, WE HAVE BEEN INFORMED BY THE DISTRIBUTOR FUKUDA DENSHI CO., LTD. HEAD OFFICE, ABOUT AN INCIDENT INVOLVING TEO-2020DR ELECTRODES AT (B)(6) CENTER. THE COMPLAINANT REPORTED: "WE HAVE RECEIVED A COMPLAINT THAT TEO-2020DR CAUSED VESICLES TO SEVERAL CHILDREN'S SKIN IN THE HOSPITAL, (B)(6) CENTER. WE HEARD CHILDREN'S AGE IS ABOUT 5 YEARS OLD ON AVERAGE. WE ALSO RECEIVED PHOTOS AND IT SEEMS THE GEL OF TEO-2020DR CAUSED THESE. (...) FORTUNATELY, THESE SKIN RECOVERED IN A FEW DAYS (...). IN ADDITION, WE GOT INFORMATION THAT THIS HOSPITAL IS USING SKIN PROTECTION SPRAY, REMOIS COAT (VERY SIMILAR TO 3M CAVILON NO STING BARRIER FILM) BEFORE APPLYING TEO-2020DR." WE WERE REQUESTING SEVERAL TIMES FOR FURTHER INFORMATION ON THE PATIENT, THE SKIN PREPARATION, THE DURATION OF APPLICATION, THE POSTION OF THE SKIN REACTIONS RELATIVE TO THE ELECTRODES AND THE PROCEDURE. THE DISTRIBUTOR INFORMED US ON MARCH 8 THAT AN UPDATE WILL ONLY BE PROVIDED IN APRIL.

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF THE SAME LOT NUMBER WERE INSPECTED VISUALLY AND MECHANICALLY. IN ADDITION, TWO ELECTRODES WERE APPLIED ON A VOLUNTEER FOR SIX HOURS. NO REACTION OR DEVIATION COULD BE OBSERVED. THE RETAINED SAMPLES WERE WITHIN SPECIFICATION. IT IS UNCLEAR WHETHER THE SKIN REACTION WAS CAUSED BY THE ECG ELECTRODES OR BY THE USAGE OF THE REMOIS COAT SPRAY (INTERACTION WITH ELECTRODE COMPONENTS OR INSUFFICIENTLY DRIED SPRAY COAT). IT IS ALSO UNCLEAR WHETHER THE SKIN REACTIONS HAD TO BE TREATED. IT WAS NOT POSSIBLE TO RECEIVE THIS INFORMATION DESPITE REPEATED REQUESTS SO FAR. WE CURRENTLY HAVE NOT ENOUGH INFORMATION TO DECIDE WHETHER THESE EVENTS CONSTITUTE REPORTABLE INCIDENTS. HOWEVER WE DECIDED TO REPORT TO ERR ON THE SAFE SIDE. WE WILL FOLLOW UP WHEN WE RECEIVE FURTHER INFORMATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2017, WE HAVE BEEN INFORMED BY THE DISTRIBUTOR (B)(4) HEAD OFFICE, ABOUT AN INCIDENT INVOLVING TEO-2020DR ELECTRODES AT (B)(6) MEDICAL CENTER. THE COMPLAINANT REPORTED: "WE HAVE RECEIVED A COMPLAINT THAT TEO-2020DR CAUSED VESICLES TO SEVERAL CHILDREN'S SKIN IN THE HOSPITAL, (B)(6) MEDICAL CENTER. WE HEARD CHILDREN'S AGE IS ABOUT 5 YEARS OLD ON AVERAGE. WE ALSO RECEIVED PHOTOS AND IT SEEMS THE GEL OF TEO-2020DR CAUSED THESE. (...) FORTUNATELY, THESE SKIN RECOVERED IN A FEW DAYS (...). IN ADDITION, WE GOT INFORMATION THAT THIS HOSPITAL IS USING SKIN PROTECTION SPRAY, REMOIS COAT (VERY SIMILAR TO 3M CAVILON NO STING BARRIER FILM) BEFORE APPLYING TEO-2020DR." WE WERE REQUESTING SEVERAL TIMES FOR FURTHER INFORMATION ON THE PATIENT, THE SKIN PREPARATION, THE DURATION OF APPLICATION, THE POSITION OF THE SKIN REACTIONS RELATIVE TO THE ELECTRODES AND THE PROCEDURE. THE DISTRIBUTOR INFORMED US ON MARCH 8 THAT AN UPDATE WILL ONLY BE PROVIDED IN APRIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204682 SNAPRODE ECG ELECTRODE DRX LEONHARD LANG GMBH F-401C 161205-0125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other