BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDY PERMA SHARP SUTURES

    MDR report key: 1701000 · Received May 26, 2010

    Report

    Report Number
    2522801-2010-00012
    Event Type
    Other
    Date Received
    May 26, 2010
    Date of Event
    March 17, 2010
    Report Date
    May 26, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
    Product Code
    GAR
    PMA / PMN Number
    K930825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED TO ANGIOTECH FOR EVAL. THIS INCIDENT WAS INITIALLY REPORTED TO (B)(4), THE DISTRIBUTOR OF THIS PRODUCT. (B)(4) THEN NOTIFIED ANGIOTECH. ONE (1) OTHER HU-FRIEDY PERMA SHARP SUTURE PRODUCT WAS ALSO REPORTED. THE PRODUCT INFO IS AS FOLLOWS: 4-0 BLACK BRAIDED SILK, MODEL/CATALOG #: PSN18507S, LOT #: M896140, EXPIRATION DATE: 04/30/2011, DEVICE MFR DATE: 04/2006; 510(K) #: K930825. METHOD: THE DEVICES WERE NOT RETURNED FOR EVAL. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED. THERE WERE NO OTHER COMPLAINTS RECEIVED FOR THESE FINISHED GOOD LOTS. THERE WERE NO QUALITY ISSUES NOTED DURING THE MFG PROCESSES OR AT FINAL RELEASE. THE STERILITY REQUIREMENTS WERE WITHIN SPECIFICATION. RESULTS/CONCLUSION: THE DEVICES WERE NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. (B)(4), ITEM # PSN683S, HU-FRIEDY PERMA SHARP SUTURE, 4-0 BBS, LOT M551750; ITEM # PSN18507S, HU-FRIEDY PERMA SHARP SUTURE, 4-0 BBS, LOT M896140.

    Description of Event or Problem · 1

    DR. (B)(6) REPORTED THAT SHE HAD ONE (1) PT PRESENT BACK TO THE OFFICE ONE (1) DAY POST-OPERATIVELY WITH "MASSIVE SWELLING" FOLLOWING A DENTAL /ORAL PROCEDURE WHERE SILK SUTURE WAS USED. NO CULTURE AND SENSITIVITIES WERE PERFORMED. THE PT WAS ADMINISTERED ORAL ANTIBIOTICS WHICH RESOLVED THE ISSUE. THE SUTURES WERE REMOVED AND THE PT'S STATUS WAS LISTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY PERMA SHARP SUTURES SUTURE AND NEEDLE GAR SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH) PSN683S M551750

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention