BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOINTRAFIX SHEATH, SMALL

    MDR report key: 1007086 · Received March 4, 2008

    Report

    Report Number
    1221934-2008-00125
    Event Type
    Injury
    Date Received
    March 4, 2008
    Date of Event
    August 1, 2007
    Report Date
    March 1, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT IN TIME, MITEK IS IN THE INFO GATHERING MODE. "WHEN ALL THE INFO AND FACTS THAT CAN BE HAD ARE HAD." WHEN ALL THE INFO AND FACTS HAVE BEEN EVALUATED, THE RESULTS OF SAID INVESTIGATION WILL BE THE SUBJECT OF A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE REPORTS TO US THAT A PT HAD A KNEE REPAIR SOMETIME IN 2007. A LETTER DATED OCTOBER 26, 2007, AUTHORED BY THE PT'S PHYSICIAN, INDICATES THAT THE PT HAD ON HIS LEFT ARM, RIGHT SIDE HIS BACK AND RIGHT LEG DEVELOPED SOME SKIN REACTIONS, LESION & PUSTULES. THESE CONDITIONS AROSE DESPITE TREATMENT WITH HIGH ORAL DOSAGES OF "FLUCLOXACILLIN" COMBINED WITH "FUCIDIN" OINTMENT. HIS CULTURE RESULTS INDICATE A FULL SENSITIVE "STAPH AUREUS". AT THIS POINT, A REGIMENT OF "CLARITHROMYCIN 500MG BD" FOR 10 DAYS AND "CHLORHEXIDINE" AND FUCIDIN. "FUCIBET" FOR TOPICAL APPLICATION TO THE ITCHY LESIONS ON THE BACK WAS ALSO INDICATED. IN A LETTER DATED NOVEMBER 16, 2007 FROM THE PHYSICIAN, THE PHYSICIAN INDICATES THAT THE PT CONTINUES TO GET NEW LESIONS DESPITE CONTINUED TREATMENT WITH CLARITHROMYCIN. FURTHER, AT THIS TIME, HE HAS ACQUIRED LESIONS ON THE PALMS AND SIDE OF THE FINGER OF THE RIGHT INDEX FINGER, SUGGESTING "POMPHOLYX" DERMATITIS; ELSEWHERE, THE LESIONS ARE SUGGESTIVE OF "STAPH FOLLICULITIS". CLARITHROMYCIN TO BE DISCONTINUED, CONTINUE WITH FUCIBET AND AN INCISION BIOPSY WITH CULTURE TO BE HAD. AS TIME PASSES, LETTERS DATED; DECEMBER 7, 2007, DECEMBER 11, 2007, DECEMBER 14, 2007 INDICATES BOTH CONTINUED REACTIONS AND POSITIVE FUNCTIONAL RECOVERY OF THE KNEE. THE PT CONTINUES TO BE TREATED WITH VARIOUS MEDICATIONS AND THE PHYSICIAN CONTINUES TO TRY AND CHASE DOWN THE UNDERLYING CAUSE OF THE REACTION. AT THIS POINT THE PHYSICIAN LOOKS TOWARDS THE FIXATION DEVICES USED IN THE KNEE REPAIR. A LETTER DATED FEBRUARY 1, 2008 RECOMMENDS THE PT TO AN ALLERGIST. MITEK HAS SUPPLIED A SAME DEVICE AS THE ONE USED IN THE KNEE REPAIR TO THE ALLERGIST SO THAT THEY MAY PERFORM A PATCH TEST. THE CONDITION OF THE PT IS AT THIS POINT IN TIME AN ONGOING EVENT. QUESTIONS ARE OUT FOR FURTHER INFO & DETAIL. ALSO SEE ASSOCIATED MDR 122194-2008-00124.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOINTRAFIX SHEATH, SMALL SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 254629 0704206

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention