BEUDAMED
    FDA Adverse Event Other Summary report: N

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

    MDR report key: 2941542 · Received January 31, 2013

    Report

    Report Number
    2246315-2013-00022
    Event Type
    Other
    Date Received
    January 31, 2013
    Report Date
    January 21, 2013
    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

    MFR'S COMMENT: NO FURTHER DETAILS WERE REC'D. FURTHER INFO HAS BEEN REQUESTED. REPORT SOURCE LITERATURE DESCRIPTION: JOURNAL: FACIAL PLAST SURG, AUTHOR: NETTAR K AND MAAS C., TITLE: FACIAL FILLER AND NEUROTOXIN COMPLICATIONS, VOLUME: 28, YEAR: 2012, PAGES: 288-293.

    Description of Event or Problem · 1

    FRANK SKIN NECROSIS OF HER FOREHEAD [SKIN NECROSIS]. CASE DESCRIPTION: LITERATURE-SPONTANEOUS REPORT WAS REC'D ON (B)(4) 2013 FROM AN AUTHOR REGARDING A (B)(6) FEMALE PT, INITIALS UNKNOWN, WITH CUTANEOUS CONTOUR DEFORMITY. THIS REPORT WAS FROM A LITERATURE ARTICLE ENTITLED "FACIAL FILLER AND NEUROTOXIN COMPLICATIONS". THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR WRINKLES IN THE GLABELLA REGION (GLABELLAR COMPLEX) AND PREVIOUS USE OF NEUROMODULATORS FOR THE GLABELLAR COMPLEX WITH MINIMAL RESULTS. ON AN UNSPECIFIED DATE, THE PT WAS ADMINISTERED WITH UNSPECIFIED MFR HYALURONIC ACID FILLER INJECTION (ROUTE AND DOSAGE REGIMEN NOT PROVIDED) FOR TREATMENT OF HER "11 LINES". THE LOT NUMBER HYALURONIC ACID FILLER WAS NOT PROVIDED. ON THE SAME DAY, IMMEDIATELY UPON INJECTING HYALURONIC ACID FILLER IN A SUBDERMAL PLANE, THE PT DEVELOPED BLANCHING OF THE FOREHEAD SUPERIOR TO THE INJECTION SITE. IT WAS REPORTED THAT UNSUSPECTINGLY, THE CLINICIAN CONTINUED TO INJECT THE FILLER, EFFACING THE GLABELLAR DEPRESSIONS. THE NEXT DAY, THE PT RETURNED, COMPLAINING OF A DARK DISCOLORATION OF HER FOREHEAD. IT WAS REPORTED THAT THE CLINICIAN CITED BRUISING AND PT WAS GIVEN TREATMENT WITH ORAL ARNICA MONTANA AND ICE COMPRESSES. ON AN UNSPECIFIED DATE, THE FOLLOWING DATE, THE FOLLOWING WEEK, PT RETURNED TO CLINIC WITH FRANK SKIN NECROSIS OF HER FOREHEAD WHICH WAS SUPERIOR TO THE INJECTION SITE ON THE RIGHT. THE PT WAS TAKEN TO THE OPERATING ROOM AND THE AFFECTED NECROTIC AREA WAS DEBRIDED. IT WAS REPORTED THAT BECAUSE OF THE PT'S SKIN LAXITY, WIDE UNDERMINING FACILITATED PRIMARY CLOSURE. THE ACTION TAKEN WITH HYALURONIC ACID FILLER TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT FRANK SKIN NECROSIS OF FOREHEAD WAS NOT PROVIDED. CONCOMITANT MEDIATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF FRANK SKIN NECROSIS OF FOREHEAD WAS NOT PROVIDED. THE REPORTING AUTHOR ASSESSED THE CAUSAL RELATIONSHIP BETWEEN HYALURONIC ACID FILLER AND THE EVENT AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43685 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 47 YR Required Intervention