BEUDAMED
    FDA Adverse Event Summary report: N

    PREVELLE SILK (NON-ANIMAL STABILIZED HYLAN B GEL WITH LIDOCAINE HCL) INJECTION

    MDR report key: 2112511 · Received April 4, 2011

    Report

    Report Number
    2246315-2011-00062
    Date Received
    April 4, 2011
    Report Date
    March 25, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    LMH
    PMA / PMN Number
    P030032/S007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 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.

    Description of Event or Problem · 1

    EDEMA OVER HER LEFT PERIORBITAL AREA [INJECTION SITE OEDEMA]. TENDER, ERYTHEMATOUS NODULES OVER THE SITES OF PRODUCT [INJECTION SITE NODULE]. ERYTHEMA OVER HER LEFT PERIORBITAL AREA [INJECTION SITE ERYTHEMA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011 FROM A DERMATOLOGIST VIA A COMPANY REP REGARDING A FEMALE PT (AGE AND INITIALS UNK). THE PT WAS INJECTED WITH PREVELLE SILK IN THE PERIORBITAL AREA, DATE NOT PROVIDED. AT THE ONE WEEK AND ONE MONTH FOLLOW-UP, NOTHING WAS PRESENT AND THE PT LOOKED GOOD. AT THE TWO MONTH FOLLOW-UP, THE PT SHOWED SOME FAINT ERYTHEMA AND EDEMA OVER HER LEFT PERIORBITAL AREA, BUT MINIMAL. AT THE THIRD MONTH VISIT, THE PT PRESENTED WITH TENDER, ERYTHEMATOUS NODULES OVER THE SITES WHERE THE PRODUCT WAS INJECTED. TREATMENT INCLUDED A 2.5 MM PUNCH BIOPSY AND INJECTION OF 2 CC OF KENALOG (TRIAMCINOLONE) 2.5% INTO ALL THREE NODULES. THE PREVELLE SILK LOT NUMBER WAS NOT PROVIDED. NO FURTHER INFO WAS PROVIDED. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2011. 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. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF PREVELLE SILK IS NOT AFFECTED BY THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREVELLE SILK (NON-ANIMAL STABILIZED HYLAN B GEL WITH LIDOCAINE HCL) INJECTION DERMAL IMPLANT FOR AESTHETIC USE LMH GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other