BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLLISTER "PLASTIBELL" SIZE 1.2CM

    MDR report key: 89915 · Received May 8, 1997

    Report

    Report Number
    1921454-1997-00001
    Event Type
    Injury
    Date Received
    May 8, 1997
    Date of Event
    March 28, 1997
    Report Date
    April 14, 1997
    Manufacturer
    HOLLISTER, INC.
    Product Code
    FHG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING POST-PARTUM OB VISIT @ PT'S HOME R/N NOTICED SWELLING OF PENIS & SCROTUM WITH DISCOLORATION OF LOWER EXTREMITIES. BABY'S MOTHER STATED INFANT HAD NOT URINATED FOR APPROX. 36 HRS. DEVICE WAS STILL IN PLACE. DR. WAS CONTACTED. INFANT WAS SEEN IN DRS OFC THEN ADMITTED TO HOSPITAL. OB PHYSICIAN WAS CALLED. DEVICE REMOVED WITHOUT DIFFICULTY. INFANT'S LOWER EXTREMITY COLOR RETURNED PINK IMMED. PT VOIDED AFTER 15 MIN. INFANT HAD BEEN CIRCUMSIZED 3/26/97. ADMITTED 3/28 - DISCHARGED 4/1/97. ANTIBIOTICS GIVEN. DIAG: CELLULITIS OF PENIS/SCROTUM URINARY OBSTRUCTION. 4/18/97 DR BELIEVES IT WAS A FOREIGN BODY REACTION (?) CAUSE. ADMISSION T.98 HIGHEST T. 3/29/97 100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER "PLASTIBELL" SIZE 1.2CM CIRCUMCISION DEVICE FHG HOLLISTER, INC. UNK 4H08B

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY Hospitalization