BEUDAMED
    FDA Adverse Event Other Summary report: N

    HU-FRIEDY PERMA SHARP SUTURES

    MDR report key: 1709329 · Received June 2, 2010

    Report

    Report Number
    2522801-2010-00013
    Event Type
    Other
    Date Received
    June 2, 2010
    Date of Event
    May 1, 2010
    Report Date
    June 2, 2010
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAL
    PMA / PMN Number
    K896554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED TO ANGIOTECH FOR EVALUATION. THIS INCIDENT WAS INITIALLY REPORTED TO HU-FRIEDY, THE DISTRIBUTOR OF THIS PRODUCT. HU-FRIEDY THEN NOTIFIED ANGIOTECH. ONE OTHER HU-FRIEDY PERMA SHARP SUTURE PRODUCT WAS ALSO REPORTED. THE PRODUCT INFORMATION IS AS FOLLOWS: 4-0 CHROMIC GUT SUTURE, MODEL/CATALOG #: PSN1654C, LOT #: UNK, EXPIRATION DATE: UNK, DEVICE MANUFACTURE DATE: UNK, 510 (K) #: K896554. METHOD: THE DEVICES WERE NOT RETURNED FOR EVALUATION. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED FOR LOT M656000. THERE WERE NO QUALITY ISSUES NOTED DURING THE MANUFACTURING PROCESSES OR AT FINAL RELEASE. THE STERILITY REQUIREMENTS WERE WITHIN SPECIFICATION. THERE WERE NO OTHER COMPLAINTS RECEIVED FOR EITHER OF THE REPORTED ITEMS. RESULTS/CONCLUSION: THE DEVICES WERE NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. (B)(4), ITEM # PSN683S, HU-FRIEDY PERMA SHARP SUTURE, 4-0 PLAIN GUT, LOT M656000, ITEM # PSN1654C, HU-FRIEDY PERMA SHARP SUTURE, 4-0 CHROMIC GUT, LOT UNK.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED. (B)(6) REPORTED THAT HE HAD TWO PATIENTS PRESENT BACK TO THE OFFICE APPROXIMATELY FOURTEEN DAYS POST OPERATIVE A SINGLE TOOTH (MOLAR) IMPLANT PROCEDURE WITH A SWOLLEN BUMP IN THE GUM TISSUE, SIMILAR TO AN ABSCESS. THE DOCTOR WAS NOT CERTAIN IF PLAIN OR CHROMIC GUT SUTURE WAS USED FOR THE PROCEDURES. BOTH PATIENTS WERE TREATED EMPIRICALLY WITH AMOXICILLIN. NO CULTURES AND SENSITIVITIES WERE COMPLETED AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE DATE OF THIS EVENT IS ESTIMATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HU-FRIEDY PERMA SHARP SUTURES SUTURE AND NEEDLE GAL SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) PSN1644A M656000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention