MAUDE Adverse Event Report: GALDERMA Q-MED SCULPTRA; IMPLANT, DERMAL, FOR AESTHETIC USE

Lot Number A8134

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hearing Impairment (1881); Nausea (1970); Tinnitus (2103); Dizziness (2194); Palpitations (2467); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The reported lot number was valid.Pharmacovigilance comment: the serious events of tinnitus and hypoacusis, and the non-serious events nausea, dizziness, balance disorder were considered unexpected, possibly related to the sculptra treatment of the preauricular and jawline area, and unrelated to the restylane lyft treatment of the lips and marionette lines given the relative proximity to the ear.Serious criteria include the need for hospitalization, multiple medical interventions and investigations, and continued medical surveillance with an ent specialist.Potential contributory factors include injection technique and concomitant treatment with toxin.Alternative etiologies for the symptoms include meniere's disease secondary to an abnormal immune response or viral infection of unrelated coincidence.The ent physician assessed causality for sculptra as unrelated; a causality assessment for restylane lyft was not provided.The case meets the criteria for expedited reporting to the regulatory authorities.Capa comment: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 14-aug-2019 by a physician which refers to a (b)(6) female patient.The patient had penicillin allergy.No information about medical history has been provided.The patient had previously received treatment with sculptra (lot a7127) on (b)(6) 2018 to right and left lateral face and mental region.On (b)(6) 2019, the patient received treatment with 1 vial sculptra (lot a8134) to pre-auricular and jawline, deep dermal subcutaneous injection with unknown needle and technique for lateral lifting.On (b)(6) 2019, the patient received treatment with 1 ml restylane lyft lidocaine (lot 16827) to lips, marionette area using dermal subcutaneous injection with unknown needle and technique for volumisation.On the same date, patient received treatment with 95 units of dysport [dysport] to frown, crow's feet, mentalis and platysma via intramuscular.24-48 hours later, on (b)(6) 2019, the patient experienced nausea(nausea),dizziness (dizziness), off balance(balance disorder) and pulsatile tinnitus (tinnitus) in left ear.The patient was hospitalized on undisclosed dates for an unknown period of time.On performing audiogram revealed high frequency hearing impairment(hypoacusis) on left side, but no prior audiogram for comparison was available.The hearing impairment was not noticed by the patient.The patient had undergone multiple investigations (including in-patient investigations) such as ct, mri brain, blood and balance tests were normal.Treatment for the adverse event included stemetil [prochlorperazine], prednisone [prednisone], serc [betahistine hydrochloride].It was reported that other events settled down except dizziness, off balance, pulsatile tinnitus and high frequency hearing impairment which were ongoing.The patient had ongoing consultation with an ent specialist who felt that sculptra was not likely a cause or contributor to the events.A causal assessment for restylane lyft was not provided.Outcome at the time of the report: dizziness was not recovered/not resolved.Off balance was not recovered/not resolved.Nausea was recovered/resolved.Pulsatile tinnitus was not recovered/not resolved.High frequency hearing impairment was not recovered/not resolved.

Manufacturer Narrative

Manufacturer narrative: the reported lot number was valid.Pharmacovigilance comment: the serious events of tinnitus and hypoacusis, and the non-serious events nausea, dizziness, balance disorder and palpitations were considered unexpected, possibly related to the sculptra treatment of the preauricular area and face, and unrelated to the restylane lyft treatment of the perioral area given the small, localized treatment of increased distance from the ear.Serious criteria include the need for hospitalization, multiple medical interventions and investigations, and continued medical surveillance with an ent specialist.Potential etiologies include postprocedural inflammation or trauma to facial nerves.Alternative etiologies for the events include meniere's disease, age-related hearing loss, and bacterial or viral infection of unrelated coincidence.Age-related high frequency hearing loss is frequently present and unrecognized until later in life.Potential contributory factors include injection technique and concomitant treatment with toxin.The ent physician assessed injectable treatment as the likeliest cause for the events, however, the results of diagnostic testing other than the audiogram were unavailable to the reporting physician.The case meets the criteria for expedited reporting to the regulatory authorities.Capa comment: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.

Event Description

Case reference number(b)(4).Is a spontaneous report sent on (b)(6)2019 by a physician which refers to a 52-year-old female patient.Additional follow up information was received on (b)(6)2019 and (b)(6)2019 from same physician.The patient had penicillin allergy.No information about medical history has been provided.The patient had previously received treatment with sculptra (lot a7127) on 24-oct-2018 to right and left lateral face and mental region.In past, the patient had another session of treatment with sculptra on an unknown date.On (b)(6)2019 , the patient received treatment with 1 vial sculptra (lot a8134) diluted in 9 ml of sterile water for injection to lateral aspect of face and pre-auricular region, deep dermal subcutaneous injection with unknown needle and technique for lateral lifting.On (b)(6)2019 , the patient received treatment with 1 ml restylane lyft lidocaine (lot 16827) to perioral region using dermal subcutaneous injection with unknown needle and technique for volumisation.On the same date, patient received treatment with 95 units of dysport [dysport] to frown, crow's feet, mentalis, platysma and perioral region via intramuscular for relaxation.24-48 hours later, on 16 or (b)(6)2019 , the patient experienced nausea(nausea), dizziness (dizziness), off balance(balance disorder), pulsatile tinnitus (tinnitus) in left ear and audible heart beat (palpitations).The patient was hospitalized on undisclosed dates for an unknown period of time.On performing audiogram revealed high frequency hearing impairment(hypoacusis) on left side, but no prior audiogram for comparison was available.The hearing impairment was not noticed by the patient.The patient had undergone multiple investigations (including in-patient investigations) such as ct, mri brain, blood and balance tests were normal.Treatment for the adverse event included stemetil [prochlorperazine], prednisone [prednisone], serc [betahistine hydrochloride].On (b)(6)2019 , it was reported that other events resolved except pulsatile tinnitus and high frequency hearing impairment which were ongoing.The reporter was not aware of any other investigations being performed since the adverse event form was submitted.The reporter was not sure of hospitalization duration, thought may be one day or night.The ent specialist appears to believe that the injectable treatment was the likeliest explanation for the events.A causal assessment for restylane lyft was not provided.On (b)(6)2019 , it was reported that events resolved except audible heart beat, pulsatile tinnitus and high frequency hearing impairment which were ongoing.Outcome at the time of the report: high frequency hearing impairment/hearing loss was not recovered/not resolved.Pulsatile tinnitus was not recovered/not resolved.Dizziness was recovered/resolved.Off balance was recovered/resolved.Nausea was recovered/resolved.Audible heart beat was not recovered/not resolved.Tracking list: v.0 initial v.1 fu received on(b)(6)2019 by physician: event outcome and reporter causality was updated.V.2 fu received on (b)(6)2019 by physician: concomitant product sterile water for injection was added.Event palpitation was added.Suspect device locations updated.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 14-aug-2019 by a physician which refers to a 52-year-old female patient.Additional follow up information was received on 03-sep-2019 from same physician.The patient had penicillin allergy.No information about medical history has been provided.The patient had previously received treatment with sculptra (lot a7127) on (b)(6) 2018 to right and left lateral face and mental region.On (b)(6) 2019, the patient received treatment with 1 vial sculptra (lot a8134) to pre-auricular and jawline, deep dermal subcutaneous injection with unknown needle and technique for lateral lifting.On (b)(6) 2019, the patient received treatment with 1 ml restylane lyft lidocaine (lot 16827) to lips, marionette area using dermal subcutaneous injection with unknown needle and technique for volumisation.On the same date, patient received treatment with 95 units of dysport [dysport] to frown, crow's feet, mentalis and platysma via intramuscular.24-48 hours later, on (b)(6) or (b)(6) 2019, the patient experienced nausea(nausea),dizziness (dizziness), off balance(balance disorder) and pulsatile tinnitus (tinnitus) in left ear.The patient was hospitalized on undisclosed dates for an unknown period of time.On performing audiogram revealed high frequency hearing impairment(hypoacusis) on left side, but no prior audiogram for comparison was available.The hearing impairment was not noticed by the patient.The patient had undergone multiple investigations (including in-patient investigations) such as ct, mri brain, blood and balance tests were normal.Treatment for the adverse event included stemetil [prochlorperazine], prednisone [prednisone], serc [betahistine hydrochloride].On (b)(6) 2019, it was reported that other events resolved except pulsatile tinnitus and high frequency hearing impairment which were ongoing.The reporter was not aware of any other investigations being performed since the adverse event form was submitted.The reporter was not sure of hospitalization duration, thought may be one day or night.The ent specialist appears to believe that the injectable treatment was the likeliest explanation for the events.A causal assessment for restylane lyft was not provided.Outcome at the time of the report: high frequency hearing impairment was not recovered/not resolved.Pulsatile tinnitus was not recovered/not resolved.Dizziness was recovered/resolved.Off balance was recovered/resolved.Nausea was recovered/resolved.Tracking list: v.0 initial.V.1 fu received on 3-sep-2019 by physician: event outcome and reporter causality was updated.

Manufacturer Narrative

Manufacturer narrative: the reported lot number was valid.Pharmacovigilance comment: the serious events of tinnitus and hypoacusis, and the non-serious events nausea, dizziness, balance disorder were considered unexpected, possibly related to the sculptra treatment of the preauricular and jawline area, and unrelated to the restylane lyft treatment of the lips and marionette lines given the relative proximity to the ear.Serious criteria include the need for hospitalization, multiple medical interventions and investigations, and continued medical surveillance with an ent specialist.Potential contributory factors include injection technique and concomitant treatment with toxin.Alternative etiologies for the symptoms include meniere's disease secondary to an abnormal immune response or viral infection of unrelated coincidence.The ent physician assessed injectable treatment as the likeliest causality for the events.The case meets the criteria for expedited reporting to the regulatory authorities.Capa comment: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.

• Brand Name: SCULPTRA
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• MDR Report Key: 8926454
• MDR Text Key: 156287855
• Report Number: 9710154-2019-00082
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P030050/S2
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: A8134
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DYSPORT; DYSPORT; DYSPORT; STERILE WATER FOR INJECTION
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR