BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2094101 · Received May 9, 2011

    Report

    Report Number
    2246315-2011-00106
    Event Type
    Other
    Date Received
    May 9, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 29, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BENEFIT-RISK RELATIONSHIP OF PREVELLE SILK IS NOT AFFECTED BY THIS REPORT. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER (B)(4), EXPIRATION DATE 08/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    SKIN NODULE OVER THE SITES OF THE PRODUCT [INJECTION SITE NODULE]. ERYTHEMATOUS OVER THE INJECTION SITE [INJECTION SITE ERYTHEMA]. EDEMA OVER LEFT PERIORBITAL AREA [INJECTION SITE OEDEMA]. URINARY TRACT INFECTION [URINARY TRACT INFECTION]. CASE DESCRIPTION: LICENSEE-SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2011, FROM A PHYSICIAN REGARDING A PATIENT, INITIALS AND GENDER UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED PREVELLE SILK, DOSE REGIMEN NOT AVAILABLE. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A SKIN NODULE AND ERYTHEMA. ACTION TAKEN WITH PREVELLE SILK WAS NOT PROVIDED. THE PATIENT'S OUTCOME WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE RELATIONSHIP BETWEEN PREVELLE SILK AND THE EVENTS WAS NOT PROVIDED BY THE REPORTING PHYSICIAN. SEE MANUFACTURERS CONTROL NUMBER (B)(4) FOR OTHER ADVERSE EVENTS FROM THIS REPORTER. 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. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011, REGARDING A (B)(6) FEMALE PATIENT, INITIALS (B)(6). THE PATIENT IS CURRENTLY PARTICIPATING IN AN INVESTIGATOR SPONSORED TRIAL ENTITLED "(B)(4)" AND PATIENT ID IS (B)(6). THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR POST MENOPAUSE AND PREVIOUS USE WITH "RADIANCE" IN 2005 AND RESTYLANE (HYALURONIC ACID) IN 2007. ON (B)(6) 2010, THE PATIENT INITIATED TREATMENT WITH PREVELLE SILK, LOT NUMBER (B)(4), DOSE REGIMEN NOT AVAILABLE, INTO HER CROW'S FEET AND LIP LINE. ON (B)(6) 2011, THE PATIENT EXPERIENCED A SKIN NODULE, ERYTHEMA, AND EDEMA AT THE PERIORBITAL SITE. THE EVENTS WERE TREATED WITH INTRALESIONAL HYALURONIDASE AND INTRALESIONAL KENALOG (TRIAMCINOLONE ACETONIDE). THE PHYSICIAN STATED THAT POSSIBLE PRECIPITATING EVENTS PRIOR TO ONSET WERE THE FOLLOWING: A URINARY TRACT INFECTION (UTI), A NEW DOG, AND THE PATIENT STARTED APPLYING LATISSE (BIMATOPROST) TO HER UPPER EYELIDS MARGIN. THE PATIENT'S OUTCOME FOR THE EVENTS WAS RECOVERED. THE INTENSITY FOR THE EVENTS OF SKIN NODULE AND ERYTHEMA WERE SEVERE. THE INTENSITY FOR THE EVENT EDEMA WAS MODERATE. ACTION TAKEN WITH PREVELLE SILK WAS NOT PROVIDED. THE REPORTING INVESTIGATOR ASSESSED THE RELATIONSHIP BETWEEN PREVELLE SILK AND THE EVENTS AS DEFINITELY RELATED. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2011. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER (B)(4), EXPIRY DATE 08/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    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 W1013

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention