BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDPOR SURGICAL IMPLANT

    MDR report key: 71071 · Received February 20, 1997

    Report

    Report Number
    1057129-1997-90001
    Event Type
    Other
    Date Received
    February 20, 1997
    Date of Event
    February 7, 1997
    Report Date
    February 19, 1997
    Manufacturer
    POREX SURGICAL INC.
    Product Code
    MBS
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MATERIAL CARVED TO NASAL SHAPE REMOVED AFTER TWO YEARS DUE TO RECURRING INFECTION. ORIGINAL DATE OF SURGERY FOR IMPLANT WAS 5/22/95. IMPLANTED AT THE BASE OF THE NOSE FOR SMR (SEROPLASTY). PT WAS SEEN POST OPERATIVELY AT ONE MONTH AND TWO MONTHS WITH NO PROBLEMS INDICATED. PT WAS SEEN IN 11/95, COMPLAINING THAT LEFT COLUMELLA WAS SLIGTLY SORE. NO TREATMENT RECOMMENDED AT THIS TIME. PT WAS TREATED FOR A SINUS INFECTION IN 2/1996 WITH ANTIBIOTICS. 5/96, PT RETURNED COMPLAINING OF SORENESS IN THE RIGHT NASAL BASE AREA (IMPLANT AREA) WITH PUSS VISIBLE FROM THE IMPLANT SITE. PT TREATED WITH 10 DAYS OF PREDNISONE AND Z-PACK (ZETHERMAX) FOR 3 WEEKS. 7/96, PT WAS SEEN WITH NOTICEABLE IMPROVEMENT, BUT STILL SOME SECRETION AT FLOOR OF RIGHT NOSTRIL. AFTER TREATMENT WITH A 4TH ROUND OF Z-PACK, ANTIBIOTICS WERE DISCONTINUED TO SEE IF SITE WOULD CONTINUE TO HEAL ON IT'S OWN. PT WAS TO RETURN IN 6 WEEKS FOR FOLLOWUP. DUE TO PERSONAL CONFLICTS, PT DID NOT RETURN UNTIL 2/2/97, AT WHICH TIME SHE WANTED THE IMPLANT REMOVED. 2/7/97, IMPLANT WAS REMOVED. 2/11/97, PT SEEN, INCISION HEALING WELL WITH NO VISIBLE DRAINING. THEY WILL RETURN THE IMPLANT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR SURGICAL IMPLANT Implant POROUS POLYETHYLENE BLOCK MBS POREX SURGICAL INC. 13MM X 38MM X 6MM 01010195

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other