BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1880548 · Received October 19, 2010

    Report

    Report Number
    2246315-2010-00211
    Event Type
    Other
    Date Received
    October 19, 2010
    Report Date
    August 9, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT. EVAL SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE; A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    DIFFICULTY WEIGHT BEARING [WEIGHT BEARING DIFFICULTY]. PEELING OF HANDS AND FEET [SKIN EXFOLIATION]. HAS NOT RECEIVED ANY RELIEF OF LEFT KNEE PAIN [DEVICE INEFFECTIVE]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A (B)(6), FEMALE, INITIALS (B)(6). THE PT HAD A HISTORY OF OSTEOARTHRITIS AND NUMEROUS DRUG ALLERGIES. THE PT EXPERIENCED PEELING OF HER HANDS AND FEET AFTER RECEIVING SYNVISC-ONE. ON (B)(6) 2010, THE PT RECEIVED ONE SYNVISC-ONE INJECTION INTO HER LEFT KNEE. THE PT REPORTED THAT SHE STARTED EXPERIENCING PEELING OF HER HANDS AND FEET AFTER RECEIVING THE SYNVISC-ONE INJECTION. THE PT REPORTED SHE HAD NO ALLERGIES TO AVIAN PRODUCTS. THE PT REPORTED HER ADVERSE EVENT REQUIRED ADDITIONAL TREATMENT AND SHE USED VITAMIN E CREAM. ADDITIONAL INFO WAS RECEIVED ON (B)(4) 2010 IN THE FORM OF QA RESULTS. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE; A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2010 FROM THE PT AND THE CASE WAS UPGRADED TO SERIOUS. THE PT REPORTED THAT SHE HAD NOT RECEIVED ANY RELIEF OF LEFT KNEE PAIN FROM THE SYNVISC-ONE INJECTION AND CONTINUED TO HAVE DIFFICULTY WEIGHT BEARING. ON (B)(6) 2010, THE PT RECEIVED A CORTISONE INJECTION INTO HER LEFT KNEE. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention