BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARVEST SMARTPREP2 CENTRIFUGE SYSTEM, APC60

    MDR report key: 2348984 · Received November 16, 2011

    Report

    Report Number
    1225520-2011-00003
    Event Type
    Injury
    Date Received
    November 16, 2011
    Date of Event
    August 5, 2011
    Report Date
    October 26, 2011
    Manufacturer
    HARVEST TECHNOLOGIES CORPORATION
    Product Code
    JQC
    PMA / PMN Number
    BK000037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS PLACED ON PROPHYLACTIC ANTIBIOTICS THE DAY BEFORE SURGERY AND CONTINUED TO TAKE THEM DURING THE COURSE OF THE INFECTION. ANTIBIOTICS WERE CHANGED DURING THE COURSE OF THE INFECTION AND A DRAIN WAS PLACED. ANTIBIOTIC THERAPY: AMOXICILLIN DAY PRIOR TO SURGERY, (B)(6) 2011 AUGMENTIN/FLAGYL, (B)(6) 2011 EXTENDED FLAGYL COURSE, (B)(6) 2011 EXTENDED AUGMENTIN COURSE. THERE WAS NO EVIDENCE AND CONTINUES TO BE NO EVIDENCE OF INFECTION ASSOCIATED WITH A ROOT CANAL OR ANY ABSCESS. THE SINUS MEMBRANE WAS INTACT AND NOT COMPROMISED. PATIENT HAD UNREMARKABLE MEDICAL HISTORY. HOSPITALIZATION WAS NOT NECESSARY. THERE WAS NO PERMANENT INJURY OR DISABILITY. INFECTION HAS RESOLVED. PATIENT IS DOING WELL TODAY AND WILL BE GETTING AN IMPLANT IN THE FUTURE.

    Description of Event or Problem · 1

    (B)(6), REPORTED THAT PATIENT HAD A SINUS AUGMENTATION PROCEDURE DUE TO INADEQUATE VERTICAL HEIGHT FOR FUTURE DENTAL IMPLANT PROCEDURE AND DEVELOPED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARVEST SMARTPREP2 CENTRIFUGE SYSTEM, APC60 PLATELET CONCENTRATION SYSTEM JQC HARVEST TECHNOLOGIES CORPORATION APC60 APC60-0101

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention REPORTER DOES NOT HAVE THE LOT NUMBERS OR EXP.| VERSED, DEMEROL, TORADOL, AND ZOFRAN, GIVEN| PLACEMENT. A RESORBABLE COLLACOTE WAS USED AS| OSTEOHEALTH: BIO-OSS NATURAL BONE GRAFTING| STARTED ANTIBIOTICS ON (B)(6) 2011, RECEIVED THE| MATERIAL PARTICLE SIZE 1.0- 2.0MM CANCELLOUS| INTRAVENOUSLY. ALSO LOCAL ANESTHETIC 2 PERCENT| WELL AS A RESORBABLE COLLAGEN OSEOSHIELD.| RECORDS, WHICH WE FOUND TO BE IN ORDER. THE| IRRADIATION AND WAS OPENED JUST PRIOR TO| REPORT FROM OTHER CUSTOMERS.| PATIENT WAS SEEN ON (B)(6),| (B)(6) 2011 PATIENT PRESENTED WITH SINUS PRESSURE,| PERCENT MARCAINE WITH 1:200 EPINEPHRINE. PATIENT| STERILIZATION RECORDS WERE ACCEPTABLE. THERE| WERE NO DEVIATIONS. WE HAVE NOT RECEIVED A SIMILAR| THIS REPORT BY REVIEWING THE PRODUCT LOT HISTORY| DATE'S FOR THESE 2 PRODUCTS. WE HAVE INVESTIGATED| FOLLOWING MEDICATIONS DURING THE PROCEDURE.| EXP. 10/2011. THIS PRODUCT IS STERILIZED BY GAMMA-| GRANULES 2.0G APPROXIMATELY 7.2CC'S. LOT # 080884,| MATERIALS USED DURING THE PROCEDURE, COMPANY:| INCREASED PAIN, SWELLING, AND SUPPURATION. OTHER| (B)(6)2011. ON| WAS ALSO MONITORED, BLOOD PRESSURE, HEART RATE,| XYLOCAINE WITH 1:100 EPINEPHRINE AS WELL AS .5| RECEIVED OXYGEN/NITROUS OXIDE VIA NASAL CANNULA.| DURING AND AFTER PROCEDURE. PATIENT ALSO,| RESPIRATORY RATE AND OXYGEN SATURATION BEFORE,