BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 2

    MDR report key: 16042872 · Received December 21, 2022

    Report

    Report Number
    MW5113950
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    December 2, 2022
    Report Date
    December 20, 2022
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DESCRIBE EVENT, PROBLEM, OR PRODUCT USE ERROR: PATIENT CAME IN ON (B)(6) 2022 FOR FILLER IN THE LIPS, CHEEKS AND MARIONETTES. PATIENT HAD STATED THAT SHE HAS HAD JUVADERM IN THE PAST BUT WAS DISSATISFIED WITH THE BALLS THAT SHE HAS FROM IT. WE DISCUSSED USING TEOSYAL RHA 2/4. PATIENT SIGNED OFF ON CONSENT AND WE INJECTED ALL AREAS. WHEN PATIENT CAME BACK ON (B)(6), SHE HAD ALREADY BEEN TO HER FAMILY DOCTOR FOR PREDNISONE AND BENADRYL, AS SHE WAS HAVING AN ALLERGIC REACTION, TO THE RHA FILLER IN HER UPPER LIP. AS OF THE (B)(6), THE CHEEKS, AND MARIONETTES WERE FINE BUT HER UPPER LIP WAS STILL SWOLLEN WITH FILLER GOING ABOVE THE UPPER LIP (LEDGE) AND TO THE WET AREA OF THE LIP IN NODULES. SHE STATED THAT HER UPPER LIP HAD TURNED DARK PURPLE AND WAS VERY SWOLLEN DURING THIS TIME. WE INJECTED HYLENEX, DILUTED AS DIRECTED INTO HER UPPER LIP. SHE IS RETURNING TO THE OFFICE ON (B)(6) 2022, WHERE WE WILL REASSESS HER FOR EITHER MORE HYLENEX TO REMOVE THE REST OF THE FILLER, OR PREPARE HER FOR FILLER WITH JUVADERM, SINCE SHE HAS HAD THIS PRODUCT BEFORE WITHOUT AN ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260449 TEOSYAL RHA 2 IMPLANT, DERMAL, FOR AESTHETIC USE LMH TEOXANE S.A.
    2260450 JUVADERM IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other HYLENEX, BENADRYL, AND PREDNISONE.