BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE PERLANE

    MDR report key: 4727691 · Received April 24, 2015

    Report

    Report Number
    9710154-2015-00022
    Event Type
    Injury
    Date Received
    April 24, 2015
    Report Date
    April 24, 2015
    Manufacturer
    GALDERMA Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P040024/S039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION: THE EVENT IS ALREADY ADDRESSED IN THE LABELING. IT IS STATED IN THE WARNING SECTION IN THE IFU FOR THE RESTYLANE FILLER RANGE OF PRODUCTS THAT THE PRODUCT SHOULD NOT BE INJECTED INTRAVASCULARLY. AS FOR OTHER INJECTABLE MEDICAL DEVICES INADVERTENT INJECTION INTO BLOOD VESSELS COULD POTENTIALLY LEAD TO VASCULAR OCCLUSION AND ISCHEMIA. NO CORRECTIVE ACTION WILL BE INITIATED. MANUFACTURER NARRATIVE: LOT NUMBER WAS NOT REPORTED AND A BATCH RECORD REVIEW CANNOT BE PERFORMED. PHARMACOVIGILANCE NARRATIVE: A CAUSAL RELATION BETWEEN THE EVENT AND THE TREATMENT PROCEDURE SEEMS POSSIBLE. THE INJECTION TECHNIQUE MAY HAVE CONTRIBUTED TO THE EVENT. THE REPORTED EVENT IS ADDRESSED IN THE LABEL. THE CASE IS ASSESSED AS SERIOUS AND REPORTABLE DUE TO THE INTERVENTION REQUIRED TO PREVENT PERMANENT DAMAGE TO BODY STRUCTURE.

    Additional Manufacturer Narrative · 1

    LAST INFORMATION RECEIVED ON (B)(6) 2015 INDICATED THAT THE PATIENT SYMPTOMS AS IMPLANT SITE INDURATION, IMPLANT SITE INFECTION AND IMPLANTS SITE WERE RECOVERING/RESOLVING BUT THE IMPLANT SITE ABSCESS WAS REPORTED AS NOT RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND A FINAL REPORT WILL BE PROVIDED AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). PMA 510(K) NO. P040024. PHARMACOVIGILANCE COMMENTS: BASED ON THE INFORMATION FROM A PATIENT, A CAUSAL RELATION BETWEEN THE EVENTS AND TREATMENT PROCEDURE CANNOT BE EXCLUDED. THE REPORTED EVENTS ARE ADDRESSED IN THE LABEL. LOT NUMBER WAS NOT REPORTED AND TRENDING ON BATCH COULD NOT BE PERFORMED. THIS CASE WAS ASSESSED AS NEEDED INTERVENTION AND HOSPITALIZATION TO PREVENT A SERIOUS DETERIORATION IN THE STATE OF HEALTH. THE TREATMENT HAS INCLUDED DRAINAGE OF THE IMPLANT SITE ABSCESS IN THE NASOLABIAL AREA AND ANTIBIOTIC TREATMENT (LEVOFLOXACIN,CLINDAMYCIN AND FLUCLOXACILLIN) THE COMPANY'S ASSESSMENT IS THEREFORE THAT THIS CASE FULFILLS THE CRITERIA FOR REGULATORY REPORTING. LAST RECEIVED INFORMATION ON (B)(6) 2015 REVEALED THAT THE PATIENT SYMPTOMS AS IMPLANT SITE INDURATION, IMPLANT SITE INFECTION AND IMPLANT SITE NODULE WERE RECOVERING/RESOLVING BUT THE IMPLANT SITE ABSCESS WAS REPORTED AS NOT RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND A FINAL REPORT WILL BE PROVIDED A SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE. MANUFACTURER AWARE OF ADVERSE EVENT. NO FURTHER INVESTIGATION IS PLANNED. CORRECTED DATA: THE EVENTS ARE ALREADY ADDRESSED IN THE LABELLING. NO REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION WILL BE INITIATED. THE EVENTS ARE ALREADY ADDRESSED IN THE LABELING. NO ACTION IS NEEDED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A LITERATURE REPORT RECEIVED ON 13-APR-2016. LANDAU; HYALURONIDASE CAVEATS IN TREATING FILLER COMPLICATIONS: DERMATOL SURG 2015;41:S347-S353. IT IS A REVIEW ARTICLE REGARDING THE USE OF HYALURONIDASE IN TREATING FILLER COMPLICATIONS. THREE CASES ARE RELATED TO THE ARTICLE: (B)(4). FIGURE 2. HYALURONIDASE TREATMENT FOR INTRAVASCULAR INJECTION HA FILLER. BLANCHING THAT APPEARED IMMEDIATELY AFTER 0.05 ML OF RESTYLANE INJECTION FOR CORRECTION OF INTERGLABELLAR WRINKLE. THIRTY MINUTES AFTER INJECTION OF HYALURONIDASE. THE ENTIRE ISCHEMIC AREA WAS INFILTRATED WITH 1,500 UNITS OF HYALASE RECONSTITUTED IN 2 ML OF PRESERVED SALINE.

    Description of Event or Problem · 1

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6) 2015 BY A CONSUMER/OTHER NON HEALTH PROFESSIONAL (THE PATIENT) WHICH REFERS TO A FEMALE AGED (B)(6) YEARS. THE PATIENT HAS NO RELEVANT MEDICAL HISTORY. THE REPORTER IS NOT AWARE OF ANY CONCOMITANT MEDICATION. INFORMATION ON ALLERGIES WAS NOT PROVIDED. THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENT WITH UNSPECIFIED FILLER. ON (B)(6) 2014, THE PATIENT RECEIVED TREATMENT WITH RESTYLANE PERLANE LIDOCAINE 1 ML (LOT NUMBER 12702, UNKNOWN NEEDLE AND TECHNIQUE) TO ORAL COMMISSURES ("MUNVINKLAR", CORNER OF THE MOUTH), NASOLABIAL FOLD. WHILE INJECTING IN LEFT SIDE, THE PATIENT EXPERIENCED A BURNING SENSATION, SWELLING AND PAIN. ON (B)(6) 2014, THE PATIENT RECEIVED TREATMENT WITH RESTYLANE SKINBOOSTER VITAL LIDOCAINE 1 ML (LOT NUMBER 12872, UNKNOWN NEEDLE AND TECHNIQUE) TO LIPS (UPPER LIP). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED INFECTION (IMPLANT SITE INFECTION) (INCLUDES REPORTED TERMS SWELLING, PUS, PAIN AND BURNING SENSATION) AT NOSE AFTER TREATMENT WITH RESTYLANE PERLANE LIDOCAINE AND RESTYLANE SKINBOOSTER VITAL LIDOCAINE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED "KULA" (IMPLANT SITE NODULE) AT FACE AFTER TREATMENT WITH RESTYLANE PERLANE LIDOCAINE AND RESTYLANE SKINBOOSTER VITAL LIDOCAINE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED "KAKA" (IMPLANT SITE INDURATION) AT FACE AFTER TREATMENT WITH RESTYLANE PERLANE LIDOCAINE AND RESTYLANE SKINBOOSTER VITAL LIDOCAINE, APPROXIMATELY 4X6CM. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN ABSCESS IN THE NASOLABIAL AREA (IMPLANT SITE ABSCESS) (INCLUDES REPORTED TERM PUS) AT FACE AFTER TREATMENT WITH RESTYLANE PERLANE LIDOCAINE AND RESTYLANE SKINBOOSTER VITAL LIDOCAINE, WHICH HAD TO BE DRAINED INDICATING HOSPITALIZATION. TREATMENT FOR THE ADVERSE EVENT INCLUDED AVELOX [LEVOFLOXACIN] (UNKNOWN AMOUNT AND DURATION), WHICH WAS DISCONTINUED DUE TO NAUSEA. INSTEAD A COMBINATION OF DALACIN [CLINDAMYCIN HYDROCHLORIDE], HERACILLIN [FLUCLOXACILLIN SODIUM] (UNKNOWN AMOUNT AND DURATION) WAS USED, AS WELL AS DRAINAGE OF ABSCESS. FU INFORMATION FROM (B)(6) 2015: ANOTHER ANTIBIOTICS (UNSPECIFIED) TREATMENT FOR ANOTHER 5-6 DAYS BEFORE SURGERY. A BACTERIAL CULTURE HAS BEEN TAKEN ON AN UNKNOWN DATE AND HAS TO THE INJECTING PHYSICIAN'S KNOWLEDGE BEEN NEGATIVE. FU INFORMATION FROM (B)(6) 2015: SOME TEST WAS CUT FROM THE AREA EVEN THOUGH THE LAB TEST WILL NOT SHOW ANYTHING DUE TO THE ANTIBIOTIC TREATMENT. AT THE TIME OF THE REPORT THE INFECTION, THE "KULA", AND "KAKA" WERE REPORTED AS RECOVERING/RESOLVING. AT THE TIME OF THE REPORT THE ABSCESS WAS REPORTED AS NOT RECOVERED/NOT RESOLVED. THE REPORTER HAS ASSESSED THE INFECTION (IMPLANT SITE INFECTION), "KULA" (IMPLANT SITE NODULE), KAKA" (IMPLANT SITE INDURATION) AND ABSCESS (IMPLANT SITE ABSCESS) AS POSSIBLE RELATED TO BOTH THE TREATMENT WITH RESTYLANE PERLANE LIDOCAINE AND THE TREATMENT WITH RESTYLANE SKINBOOSTER VITAL LIDOCAINE. THE COMPANY HAS ASSESSED INFECTION (IMPLANT SITE INFECTION), "KULA" (IMPLANT SITE NODULE), KAKA" (IMPLANT SITE INDURATION) AND ABSCESS (IMPLANT SITE ABSCESS) AS POSSIBLE RELATED TO BOTH THE TREATMENT WITH RESTYLANE PERLANE LIDOCAINE AND THE TREATMENT WITH RESTYLANE SKINBOOSTER VITAL LIDOCAINE. FU INFORMATION RECEIVED BY THE INJECTING PHYSICIAN ON (B)(6) 2015: INCREASING SWELLING AND REDNESS THE DAY AFTER THE INJECTION (ON THE LEFT SIDE OF NOSE). THE PATIENT WAS REMITTED TO THE HAND AND PLASTIC SURGERY CLINIC IN (B)(6). THE REPORTING PHYSICIAN CONSIDERS IT BEHAVES LIKE A INFECTIOUS PROCESS. THE CULTURE THAT HAS BEEN PERFORMED HAS TO THE PHYSICIAN'S KNOWLEDGE BEEN NEGATIVE. THE PHYSICIAN ASKS HIMSELF: LOW VIRULENT INFECTION AND FOREIGN BODY (FROM PERLANE)? THE PHYSICIAN CONSIDERS THE EVENT RELATED, POSSIBLY RELATED TO THE PRODUCT. THE REPORTER ASSESSED THE CASE AS NOT SERIOUS. THE PATIENT HAD POSSIBLY PREVIOUSLY RECEIVED TREATMENT WITH UNSPECIFIED FILLER. THE LOT NUMBER 12702 CORRESPONDS TO RESTYLANE PERLANE LIDOCAINE. THE LOT NUMBER 12872 CORRESPONDS TO RESTYLANE SKINBOOSTER VITAL LIDOCAINE. ON (B)(6) 2014, THE PATIENT RECEIVED TREATMENT WITH RESTYLANE PERLANE LIDOCAINE (1ML, UNKNOWN NEEDLE AND TECHNIQUE) TO NASOLABIAL FOLD AND ORAL COMMISSURES, AND RESTYLANE SKINBOOSTER VITAL LIDOCAINE (1ML, UNKNOWN NEEDLE AND TECHNIQUE) TO LIPS (UPPER). FU INFORMATION RECEIVED BY THE PATIENT ON (B)(6) 2015: THE PATIENT INFORMED THAT SHE IS TO VISIT THE PHYSICIAN NEXT WEEK (TUESDAY) SINCE SHE HAS PROBLEMS AGAIN, THE INFECTION DEPARTMENT WILL TAKE A BIOPSIES IN ORDER TO SEE IF THERE IS STILL BACTERIA LEFT IN RESTYLANE OR THE OTHER PRODUCT. HER ANTIBIOTIC TREATMENT WILL END ON FRIDAY ((B)(6) 2015). SHE DESCRIBES THAT SHE HAS BEEN ABLE TO REMOVE RESTYLANE EARLIER BUT IT FORMS A HARD LUMP AND AFTER THIS THE INFECTION APPEAR. ON (B)(6) 2015 THE PATIENT SENT PICTURE WITH A COMMENT THAT SHE IS NOW ALL SWOLLEN AGAIN. FU INFORMATION RECEIVED BY THE PATIENT ON (B)(6) 2015: THE PATIENT URGENTLY WENT TO THE HOSPITAL ON (B)(6) 2015. SOME TEST WAS CUT FROM THE AREA EVEN THOUGH THE LAB TEST WILL NOT SHOW ANYTHING DUE TO THE ANTIBIOTIC TREATMENT. THE PATIENT IS NOW ON ANOTHER ANTIBIOTIC TREATMENT FOR YET ANOTHER 5-6 DAYS BEFORE INDICATED FURTHER SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274791 RESTYLANE PERLANE IMPLANT, DERMAL, FOR AESTHETIC USE (LMH) LMH GALDERMA Q-MED 12872

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R