BEUDAMED
    FDA Adverse Event Summary report: N

    MALONEY TAPERED MERCURY-FILLED ESOPHAGEAL BOUGIES

    MDR report key: 91431 · Received January 23, 1995

    Report

    Report Number
    91431
    Date Received
    January 23, 1995
    Date of Event
    October 31, 1994
    Report Date
    December 7, 1994
    Manufacturer
    PILLING COMPANY
    Product Code
    KCD
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WITH HISTORY OF RECURRENT HIATUS HERNIA REFLUX AND STRICTURE UNDERWENT DILATATION WITH #42 AND #44 MALONEY DILATORS. FOLLOWING THE PASSAGE OF THE #44 DILATOR UPON RELOOKING A SMALL PERFORATION WAS DETECTED ABOVE THE STRICTURE. THE PT WAS TREATED NON-SURGICALLY WITH IV CONTROL OF ACID, NG SUCTION AND ANTIBIOTIC THERAPY. PHYSICIAN CONCLUDED THAT THE SHORT TAPERED MALONEY DILATORS ARE A LITTLE MORE RIGID AND LESS FLEXIBLE THAN THE FORMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALONEY TAPERED MERCURY-FILLED ESOPHAGEAL BOUGIES MERCURY-FILL BOUGIES KCD PILLING COMPANY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR