BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTABLE GEL

    MDR report key: 1668381 · Received April 22, 2010

    Report

    Report Number
    2032896-2010-00012
    Event Type
    Other
    Date Received
    April 22, 2010
    Report Date
    April 21, 2010
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P040024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER AND EXPIRATION DATE WERE REPORTED AS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL PMA/510(K): P020023.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A SPONTANEOUS REPORT BY A DERMATOLOGIST AND A REGISTERED NURSE WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A (B)(6) FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2010, FROM A REGISTERED NURSE. BASED ON THE INFORMATION RECEIVED, THE CASE WAS UPGRADED TO NON-SERIOUS, UNEXPECTED. MEDICAL HISTORY INCLUDED SALINE BREAST IMPLANTS (REPORTED AS "SEVERAL YEARS AGO" FROM THE DATE OF THE REPORT), PREVIOUS 1 SYRINGE INJECTION OF RESTYLANE (AMOUNT UNKNOWN) ON AN UNKNOWN DATE (REPORTED AS "ABOUT 2 YEARS AGO" FROM THE DATE OF THE REPORT) TO THE UPPER AND LOWER LIPS WHICH RESULTED IN THE PATIENT'S LIPS BEING UNEVEN AND NO PREVIOUS INJECTION OF PERLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER); THE PATIENT WAS OTHERWISE HEALTHY WITH NO MEDICAL CONDITIONS. THE PATIENT'S SKIN TYPE WAS FITZPATRICK TYPE 2. CONCOMITANT MEDICATIONS IN 2008 INCLUDED EFFEXOR (VENLAFAXINE HYDROCHLORIDE) AND AN UNSPECIFIED HORMONE REPLACEMENT PATCH. IT WAS UNKNOWN IF THE PATIENT WAS USING THESE MEDICATIONS AT THE TIME OF INJECTION WITH RESTYLANE. THE PATIENT RECEIVED A 1 SYRINGE INJECTION OF RESTYLANE (AMOUNT UNKNOWN) TO THE UPPER AND LOWER LIPS ON AN UNKNOWN DATE (REPORTED AS "ABOUT 2 YEARS AGO" FROM THE DATE OF THE REPORT) TO THE UPPER AND LOWER LIPS BECAUSE HER LIPS WERE UNEVEN. THE INJECTION TECHNIQUE WAS REPORTED AS UNKNOWN. PRE-PROCEDURE MEDICATIONS USED WERE REPORTED AS UNKNOWN. NO ADDITIONAL PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON (B)(6) 2010, A FAX WAS RECEIVED STATING A PATIENT EXPERIENCED AN ADVERSE EVENT, NO FURTHER INFORMATION WAS REPORTED AT THIS TIME. ON (B)(6) 2010, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE REGISTERED NURSE. ON AN UNKNOWN DATE, AFTER THE IMPLANTATION, THE PATIENT BEGAN HAVING "SOME TYPE OF" FOREIGN BODY REACTION [ALSO REFERRED TO AS AN IMMUNOGLOBULIN G (IGG) ANTIBODY REACTION] AFTER HER SECOND RESTYLANE INJECTION. THE PATIENT'S SYMPTOMS INCLUDED WEAKNESS AND GENERALIZED ACHINESS/FLU-LIKE SYMPTOMS. THE PATIENT HAD BEEN EVALUATED BY MANY "DIFFERENT" PHYSICIANS AND WAS AT ONE POINT DIAGNOSED WITH LYME'S DISEASE; HOWEVER, THIS DIAGNOSIS WAS LATER NEGATED. THE PATIENT WAS EVENTUALLY REFERRED TO AN INFECTIOUS DISEASE PHYSICIAN WHO ASKED THE PATIENT IF SHE HAD EVER HAD ANY TYPE OF COSMETIC INJECTIONS ANYWHERE IN HER BODY. THE PATIENT REPORTED SHE HAD RESTYLANE IMPLANTS. THE INFECTIOUS DISEASE PHYSICIAN FELT THAT THE PATIENT'S REACTION WAS PROBABLY RELATED TO RESTYLANE AND SHE WAS DIAGNOSED WITH FOREIGN BODY REACTION. THE PATIENT WAS THEN EVALUATED BY A MAXILLARY PLASTIC SURGEON. ACCORDING TO THE PATIENT, THE PLASTIC SURGEON AND THE INFECTIOUS DISEASE PHYSICIAN STATED THAT HER SYMPTOMS WOULD CONTINUE UNTIL ALL OF THE RESTYLANE WAS REMOVED. THE PLASTIC SURGEON EXCISED SOME OF THE RESTYLANE FROM THE PATIENT'S UPPER AND LOWER LIPS. PER THE PATHOLOGY REPORT DATED (B)(6) 2010, THE PATIENT HAD LESIONS TO HER LIPS FOR MORE THAN ONE YEAR, WHICH DID NOT RESPOND TO PREDNISONE. THE CLINICAL DIAGNOSIS WAS FOREIGN BODY REACTION, LYMPHEDEMA AND ALLERGIC REACTION. ON (B)(6) 2010, THE PATIENT WAS EVALUATED BY A DERMATOLOGIST TO SEE IF THE PLASTIC SURGEON "DID A GOOD JOB" AND FOR A SECOND OPINION TO SEE IF SHE SHOULD RETURN TO HAVE THE REMAINDER OF THE RESTYLANE EXCISED FROM HER LIPS, AS WAS ADVISED BY THE PLASTIC SURGEON. THE DERMATOLOGIST NOTED, THE PLASTIC SURGEON DID A GOOD JOB AND THE PATIENT WAS HEALING WELL. THE PATIENT'S LIPS WERE SLIGHTLY SWOLLEN FROM THE EXCISION SURGERY; OTHERWISE THE RESULTS OF THE SURGICAL EXCISIONS LOOKED FINE. THE PATIENT WAS ADVISED BY THE DERMATOLOGIST TO FOLLOW THE PLASTIC SURGEON'S RECOMMENDATIONS AND HAVE THE REMAINDER OF THE RESTYLANE EXCISED. THE PATIENT WAS ALSO ADVISED TO INFORM THE INJECTING DERMATOLOGIST OF HER EXPERIENCE. AS OF (B)(6) 2010, THE PATIENT'S SYMPTOMS CONTINUED. THE PATIENT WAS SCHEDULED FOR ANOTHER EXCISION BY THE PLASTIC SURGEON ON (B)(6) 2010, AND THE DERMATOLOGIST HAD NO PLANS TO SEE THE PATIENT AGAIN. THE DERMATOLOGIST DID NOT KNOW IF RESTYLANE CAUSED THE REPORTED EVENTS. THE DERMATOLOGIST ONLY KNEW WHAT THE PATIENT REPORTED TO HIM, AS HE WAS NOT THE INJECTING DERMATOLOGIST. NO COMMENTS WERE MADE BY THE DERMATOLOGIST REGARDING THE SEVERITY OF THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTABLE GEL INJECTABLE DERMAL FILLER LMH Q-MED AB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR UNSPECIFIED HORMONE REPLACEMENT PATCH| EFFEXOR (VENLAFAXINE HYDROCHLORIDE)