BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESTYLANE INJECTIBLE GEL

    MDR report key: 633604 · Received September 7, 2005

    Report

    Report Number
    9710154-2005-00023
    Event Type
    Other
    Date Received
    September 7, 2005
    Date of Event
    August 23, 2005
    Report Date
    September 6, 2005
    Manufacturer
    Q-MED AB
    Product Code
    LNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSINAL REPORTED THAT A 34 YEAR-OLD FEMALE PT UNDERWENT INJECTIONS OF RESTYLANE ON 8/22/2005 INTO THE LIPS. 0.3 CC WERE INJECTED IN THE UPPER LIP, 0.4 CC IN THE LOWER LIP AND THE REMAINDER OF THE 1 CC RESTYLANE SYRINGE WAS INJECTED IN THE LEFT NASOLABLIAL FOLD. ANESTHESIA IN THE FORM OF INFERIOR AVEOLOAR NERVE BLOCK WITH 1% LIDOCAINE/EPINEPHRINE WAS USED PRE-PROCEDURE. POST-INJECTION THE PT DID NOT PRESENT EVIDENCE IMMEDIATE BLANCHING, PAIN, SWELLING OR BRUISING. ON 8/23/2005 THE PT PHONED THE INJECTING PHYSICIAN'S OFFICE TO COMPLAIN OF BRUISING AND SWELLING OF THE LOWER LIP, THE PHYSICIAN ADVISED HER TO APPLY ICE IN THE AREA. THE PT CALLED AGAIN ON 8/24/2004 AND REPORTED THAT HEE LOWR LIP WAS VERY SWOLLEN AND PAINFUL WITH NO IMPROVEMENT IN THE BRUISING, SHE ALSO REPORTED SOME ULCERS IN THE ORAL MUCOSA INSIDE THE LIP AND THE FLOOR OF THE MOUTH; THE PHYSICAN ASKED THE PT TO GO TO THE CLINIC FOR EXAMINATION AND THE PT DECLINDED, THE PHYSICIAN PRESCRIBED VALTREX AAND CLARINEX VIA PHONE. THE PT DID NOT START THE TREATMENT UNITL THE 8/25/2005. THE PT WAS SEEN IN THE OFFICE ON 26 AUGUST, HER LOWER LIP WAS SWOLLEN WITH ULCERCATIONS IN THE ORAL MUCOSA, THE VERMILION BORDER WAS AT INTEGRUM AND HER LIP WAS PINK. THE PHYSICIAN APPLIED EMLA CREAM THAT RESULTED IN SOME RELIEF. ON 8/29/2005 SHE WAS SEEN AGAIN AT THE PHYSICIAN'S OFFICE AND THERE WAS CLEAR EVIDENCE OF NECROSIS OF THE LOWER LIP, WHICH HE DESCRIBED AS A COMPLETE BLACK ESCHAR. SHE WAS ADMITTED TO THE HOSP THE SAME DAY AND STARTED ON IV ANTIBIOTICS, IN ADDITION TO THE VALTREX, BACTOBAM AND VALIUM. SHE WAS ALSO DIAGNOSED WITH ORAL CELLULITUS. THE PHYSICIAN'S OPINION IS THAT THIS CASE OF NECROSIS WAS INDUCED BY A COMBINATION OF FACTORS REPORTED BY THE PT DURING FOLLOW-UP VISITS, SUCH AS THE FACT THAT SHE SPENT THE WEEK POST-IMPLANT EXPOSED TO HEAVY SECOND HAND SMOKING FROM HER MOTHER, THE PHYSICAN BELIEVES THAT THE VASOCONSTRICTOR EFFECT OF THE NICOTINE PLAYED A ROLE, THE PT ALSO SHARED THE SAME CUP WITH HER MOTHER WHO HAD AN ACTIVE COLD SORE, AND IN ADDITION SHE REPORTED THAT HER DOG WAS LICKING HER LIPS DURING THE DAYS FOLLOWING THE IMPLANT. DURING FOLLOW-UP CONTACT WITH THE PHYSICIAN ON 9/9/2005 HE REPORTED THAT THE PT WAS DISCHARGED FROM THE HOSP ON 9/6/2005 WITH SIGNIFICANT STRUCTURAL DAMGAE OF THE LOWER LIP. HE WAS CONSULTING WITH OTHER COLLEAGUES THE POSSIBIBLITY TO PERFORM RECONSTRUCTIVE SURGERY AND SKIN GRAFT. THE PHYSICIAN REPORTED THAT HE SAW THE PT AT HIS OFFICE LATER ON 9/9/2005 AND HER LIP HAD A BETTER APPERANCE, INCLUDING ABOUT 2/3 OF THE MEDIAL AREA BECOMING PINK, HE DESCRIBED THAT THERE WAS AN AREA OF APPROX 3 CM X 1 MM ALONG THE VERMILION BORDER THAT WAS STILL BLACK AND HE BELIVES THAT HE WILL BE ABLE TO REPAIR THE DAMAGED AREA WITH PRIMARY CLOSURE AND THERE WILL BE NO NEED OF GRAFTING. THE PT CONTINUES ON VALTREX, BACTROBAN AND CEFTIL. FURTHER INFO WILL BE REQUESTED.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT A PT UNDERWENT INJECTIONS OF RESTYLANE IN AUGUST 2005 INTO THE LIPS. 0.3 CC WERE INJECTED IN THE UPPER LIP, 0.4 CC IN THE LOWER LIP AND THE REMAINDER OF THE 1 CC RESTYLANE SYRINGE WAS INJECTED IN THE LEFT NASOLABIAL FOLD. ANESTHESIA IN THE FORM OF INFERIOR ALVEOLAR NERVE BLOCK WITH 1% LIDOAINE/EPINEPHRINE WAS USED PRE-PROCEDURE. POST-INJECTION THE PT DID NOT PRESENT EVIDENCE IMMEDIATE BLANCHING, PAIN, SWELLING OR BRUISING. THE NEXT DAY THE PT PHONED THE INJECTING PHYSICIAN'S OFFICE TO COMPLAIN OF BRUISING AND SWELLING OF THE LOWER LIP, THE PHYSICIAN ADVISED PT TO APPLY ICE IN THE AREA. THE PT CALLED AGAIN NEXT DAY AND REPORTED THAT THEIR LOWER LIP WAS VERY SWOLLEN AND PAINFUL WITH NO IMPROVEMENT IN THE BRUISING, PT ALSO REPORTED SOME ULCERS IN THE ORAL MUCOSA INSIDE THE LIP AND THE FLOOR OF THE MOUTH, THE PHYSICIAN ASKED THE PT TO GO TO THE CLINIC FOR EXAMINATION AND THE PT DECLINED, THE PHYSICIAN PRESCRIBED VALTREX AND CLARINEX VIA PHONE. THE PT DID NOT START THE TREATMENT UNTIL THE NEXT DAY. THE PT WAS SEEN IN THE OFFICE NEXT DAY, THEIR LOWER LIP WAS SWOLLEN WITH ULCERATIONS IN THE ORAL MUCOSA, THE VERMILION BORDER WAS AT INTEGRUM AND THEIR LIP WAS PINK. THE PHYSICIAN APPLIED EMLA CREAM THAT RESULTED IN SOME RELIEF. THREE DAYS LATER PT WAS SEEN AGAIN AT THE PHYSICIAN'S OFFICE AND THERE WAS CLEAR EVIDENCE OF NECROSIS OF THE LOWER LIP, WHICH PHYSICIAN DESCRIBED AS A COMPLETE BLACK ESCHAR. PT WAS ADMITTED TO THE HOSP THE SAME DAY AND STARTED ON IV ANTIBIOTICS, IN ADDITION TO THE VALTREX, BACTROBAM AND VALIUM. PT WAS ALSO DIAGNOSED WITH ORAL CELLULITIS. THE PHYSICIAN'S OPINION IS THAT THIS CASE OF NECROSIS WAS INDUCED BY A COMBINATION OF FACTORS REPORTED BY THE PT DURING FOLLOW-UP VISITS, SUCH AS THE FACT THAT PT SPENT THE WEEK POST-IMPLANT EXPOSED TO HEAVY SECOND HAND SMOKING FROM FAMILY MEMBER, THE PHYSICIAN BELIEVES THAT THE VASOCONSTRICTOR EFFECT OF THE NICOTINE PLAYED A ROLE, THE PT ALSO SHARED THE SAME CUP WITH FAMILY MEMBER WHO HAD AN ACTIVE COLD SORE, AND IN ADDITIONAL PT REPORTED THAT THEIR DOG WAS LICKING THEIR LIPS DURING THE DAYS FOLLOWING THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTYLANE INJECTIBLE GEL INJECTABLE DERMAL FILLER LNM Q-MED AB NI 7483

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| O