BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HA DERMAL FILLER

    MDR report key: 3237462 · Received July 17, 2013

    Report

    Report Number
    2024601-2013-00675
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    March 15, 2002
    Report Date
    September 12, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP WITH THE AUTHORS OF THE ARTICLE ARE IN PROGRESS; INFORMATION SUCH AS THE LOT NUMBER OF THE DEVICE IS NOT AVAILABLE AT THIS TIME. DEVICE LABELING: UNDESIRABLE EFFECTS. THE PATIENTS MUST BE INFORMED THAT THEY ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS PRODUCT, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYED. THESE INCLUDE, BUT ARE NOT LIMITED TO: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.) WHICH MAY BE ASSOCIATED WITH ITCHING OR PAIN ON PRESSURE OR BOTH, OCCURRING AFTER THE INJECTION. PATIENTS MUST REPORT INFLAMMATORY REACTIONS WHICH PERSIST FOR MORE THAN ONE WEEK OR ANY OTHER SECONDARY EFFECT WHICH DEVELOPS, TO THEIR DOCTOR AS SOON AS POSSIBLE. THE DOCTOR SHOULD USE AN APPROPRIATE TREATMENT.

    Description of Event or Problem · 1

    IN THE ARTICLE "CLINICAL EXPERIENCE WITH COMPLICATIONS OF HAND REJUVENATION" JOURNAL OF PLASTIC, RECONSTRUCTIVE, AND AESTHETIC SURGERY (2012) 65, THE AUTHORS DESCRIBE A "RETROSPECTIVE REVIEW OF THE MANAGEMENT OF 15 PATIENTS WHO PRESENTED WITH COMPLICATIONS FROM THE INJECTION OF SYNTHETIC FILLERS FOR HAND REJUVENATION" OVER A PERIOD OF 10 YEARS. OF THE 15 PATIENTS, 3 WERE INJECTED WITH HA FILLER. PATIENT "8" LISTED IN TABLE 2 DEVELOPED "INFLAMMATORY SYMPTOMS" 7 MONTHS AFTER INJECTION WITH A HA FILLER FOR "HAND REJUVENATION". PATIENT WAS TREATED WITH "ANTIBIOTICS AND HYALURONIDASE INJECTION". PER THE AUTHORS: "OUR INITIAL ANTIBIOTIC REGIMEN CONSISTED OF AT LEAST A TWO-DRUG THERAPY, SUCH AS A SECOND-GENERATION CEPHALOSPORIN AND A THIRD-GENERATION MACROLIDE, FOR 7 DAYS". UNKNOWN IF SYMPTOMS HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330683 UNK HA DERMAL FILLER LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention