BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3181507 · Received June 17, 2013

    Report

    Report Number
    2246315-2013-00359
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    June 7, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WAS RECEIVED ON (B)(4) 2013 IN THE FORM OF QA (QUALITY ASSURANCE) INVESTIGATION 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 SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. 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. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC-ONE IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    STRONG PAIN AFTER THE INJECTION/PAIN WAS VERY BAD [PAIN]. HE COULDN'T WALK ON IT/ COULD NOT GET TO THE GP [ABASIA]. TINY BIT RED [ERYTHEMA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013, FROM AN OTHER NON-HEALTH PROFESSIONAL REGARDING A MALE PT (AGE NOT PROVIDED), INITIALS UNK. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR RHEUMATOID ARTHRITIS AND EMPHYSEMA. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC ONE (HYLAN G F 20) INJECTION, DOSAGE REGIMEN AND FREQUENCY NOT PROVIDED. THE LOT NUMBER FOR SYNVISC ONE WAS NOT PROVIDED. THE SAME DAY, THE PT BEGAN FEELING STRONG PAIN AFTER THE INJECTION AND IT WAS SO MUCH THAT THE PT COULD NOT WALK ON IT AND COULD NOT GET TO THE PHYSICIAN. THE EVENT OF STRONG PAIN AFTER THE INJECTION WAS ASSESSED AS SERIOUS DUE TO HOSPITALIZATION. THE PT WAS EXAMINED AND FOUND TO HAVE NO BLOOD CLOTS, NO INFECTIONS AND X-RAY SHOWED EVERYTHING OKAY. THE PT WAS A TINY BIT RED BUT THE PAIN WAS VERY BAD. ON AN UNSPECIFIED DATE, THE PT RECEIVED TREATMENT WITH PAIN KILLERS AT THE HOSPITAL DUE TO PAIN. THE ACTION TAKEN WITH SYNVISC ONE TREATMENT WAS NOT PROVIDED. AS OF (B)(6) 2013, THE PT HAD NOT YET RECOVERED FROM THE EVENT OF 'STRONG PAIN AFTER THE INJECTION' BUT WAS DISCHARGED FROM THE HOSPITAL. THE OUTCOME FOR THE EVENTS OF 'COULD NOT WALK ON IT' AND 'TINY BIT RED' WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE PLAVIX (CLOPIDOGREL), ENDEP (AMITRIPTYLINE HYDROCHLORIDE), OXYCONTIN (OXYCODONE HYDROCHLORIDE), MOBIC (MELOXICAM), PREDNISONE, ARAVA (LEFLUNOMIDE), SOMAC (PANTOPRAZOLE SODIUM) AND ENDONE (OXYCODONE HYDROCHLORIDE). THE INTENSITY FOR THE EVENTS WAS NOT PROVIDED. THE CAUSAL RELATIONSHIP OF SYNVISC ONE WITH THE EVENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273629 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization ENDONE (OXYCONDONE HYDROCHLORIDE): UNK TO UNK| OXYCONTIN (OXYCONDONE HYDROCHLORIDE): UNK TO UNK| ARAVA (LEFLUNOMIDE): UNK TO UNK| SOMAC (PANTOPRAZOLE SODIUM): UNK TO UNK| PREDNISONE (PREDNISONE): UNK TO UNK| PLAVIX (CLOPIDOGREL): UNK TO UNK| ENDEP (AMITRIPTYLINE HYDROCHLORIDE): UNK TO UNK| MOBIC (MELOXICAM): UNK TO UNK