BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB3 CAPSULE, 1-PACK

    MDR report key: 6142871 · Received December 2, 2016

    Report

    Report Number
    9710107-2016-01121
    Event Type
    Injury
    Date Received
    December 2, 2016
    Report Date
    November 15, 2016
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    NEZ
    PMA / PMN Number
    K123864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE REFERENCE NUMBER: (B)(4). TO ERR ON THE SIDE OF PRECAUTION, THIS FOLLOWING COMPLAINT HAS BEEN CLASSIFIED AS A SERIOUS INJURY AS THE PATIENT MENTIONED GOING IN FOR AN X-RAY FOR A RETAINED CAPSULE, HOWEVER, DID NOT PROVIDE CONTACT INFORMATION FOR FOLLOW UP, THEREFORE, WE COULD NOT CONFIRM IF AN X-RAY OR ANY OTHER MEDICAL INTERVENTION WAS DONE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A PATIENT CALLED REQUESTING INFORMATION FOR THE PILLCAM PROCEDURE. THE PATIENT WANTED TO KNOW IF SHE COULD GO GET AN X-RAY DONE BECAUSE SHE BELIEVED SHE HAD A RETAINED CAPSULE. THE PATIENT DID NOT PROVIDE A DATE IN WHICH THE PROCEDURE TOOK PLACE BUT SHE HAD BEEN TRYING TO GET ASSISTANCE FROM THE PHYSICIAN FOR OVER A MONTH WITH NO RESPONSE. SHE STATED THE PHYSICIAN WOULD NOT RETURN HER CALLS AND SHE REFUSED TO PROVIDE ANY CONTACT INFORMATION FOR HERSELF OR THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793154 PILLCAM SB3 CAPSULE, 1-PACK SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN LTD (ISRAEL) FGS-0391

    Patients

    Seq Age Sex Outcome Treatment
    1 Other