BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 1914497 · Received November 29, 2010

    Report

    Report Number
    2246315-2010-00236
    Event Type
    Other
    Date Received
    November 29, 2010
    Report Date
    November 15, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    LMH
    PMA / PMN Number
    P030032/S007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 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

    ADVERSE EVENT [ADVERSE EVENT]. CASE DESCRIPTION: LICENSEE-SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A FEMALE PT, INITIALS (B)(6). THE PT HAD AN UNK MEDICAL HISTORY. ON AN UNSPECIFIED DATE, THE PT RECEIVED PREVELLE SILK. THE PT REPORTED THAT 24 HRS POST HYALURONIC ACID INJECTION, SHE STARTED STEROID TREATMENT AND WAS HOPING TO SEE SOME RESOLUTION IN A WEEK. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. NO ADDITIONAL INFO WAS PROVIDED. 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)(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. MFR'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 Required Intervention