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

Lot Number UNKNOWN

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

Patient Problems Abrasion (1689); Hair Loss (1877); Headache (1880); Nausea (1970); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Chronic Obstructive Pulmonary Disease (COPD) (2237); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Fluid Discharge (2686); Foreign Body In Patient (2687); Pericardial Effusion (3271); Dysgeusia (4424); Unspecified Eye / Vision Problem (4471); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2009

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on 06-oct-2021 by a (b)(6) female patient, who reports her own case.Additional information was received on 07-oct-2021 from the patient herself and on 20-oct-2021 from the injecting hcp.No information about medical history, history of allergies or previous filler treatments has been provided.The patient's father had alzheimer's.Concomitant treatments included vitamin d3 [vitamin d3], prednisone [prednisone] 5mg daily, morphine sulfate [morphine sulfate] 30 mg, biotene [fluorine;xylitol] spiriva respimat [tiotropium bromide monohydrate], citalopram [citalopram], furosemide [furosemide] 20 mg daily, doxycycline [doxycycline] 100mg, alprazolam [alprazolam] 1mg daily, ropinirole [ropinirole] and ondansetron [ondansetron].In (b)(6) 2009, the patient visited a physician for lipo-suction of lower face, chemical peel and sculptra injections into both cheeks (unknown amount, lot number, injection technique and needle type).On an unknown date between (b)(6) 2009 and (b)(6) 2010, the patient reported that at the time she saw the hcp for follow-up (unknown date), she had developed an intermittent sensation of sour taste(dysgeusia) when eating and the hcp had denied anything to do with the procedure.The patient reported that at a later appointment, another hcp identified the sour taste sensation as no bite syndrome caused by nerve damage (nerve injury).The patient further reported that in (b)(6) 2010, the patient noticed acne/developed into white large cluster like lesions (acne pustular) to her jawline.The acne had moved to her left cheek and developed into white large cluster like lesions that would ooze white to clear stringy material(discharge).The patient reported that she had to use a tweezers to pull the stringy material out and at the ends of the strings there would be a small ball causing the openings to become larger.The lesions moved to the right cheek and then down to her neck, breasts, abdomen, left leg, ankle and toes.She reported the lesions moved to her right foot and up her right leg then to arms and hands.The patient had lost fingernails/lost a toenail (onychomadesis) due to these lesions forming under the nails and had also lost a toenail.The patient reported that the events were cyclical, lasting over a year for each cycle.The patient reported she had major scarring (scar) caused by the lesions.The patient had seen 36 different physicians but refused to provide any contact details for any treatment providers and numerous providers had abruptly resigned after caring for her.The patient reported she was diagnosed with self mutilating behavior(intentional self-injury) and was referred to a psychiatrist.In addition to these lesions, the patient had nausea(nausea), headaches(headache), diagnosed with copd(chronic obstructive pulmonary disease) and sleep apnea(sleep apnoea syndrome), right eye drains thick fluid (eye discharge), excess bodily fluid(oedema), drools nightly thick bloody fluid sometimes white fluid (drooling) that the patient believed to be sculptra.She also reported that these lesions had recently appeared on her head causing hair loss (alopecia) and causing pain (pain).The patient reported that at the last hospital visit, she was diagnosed with fluid around the heart (pericardial effusion) and also she had been suffering with some confusion (confusional state).All symptoms were ongoing, none had resolved.The patient also reported that sculptra has spread all over the inside of body (device dislocation), was painful and came out in tears, urine and when she coughed.Her quality of life was greatly diminished.The patient reported that healthcare providers were denying her symptoms were related to sculptra, reporting that she was self-mutilating.Treatment for the adverse event was not reported.Outcome at the time of the report: nerve damage was not recovered/not resolved/ongoing.Intermittent sensation of sour taste was not recovered/not resolved/ongoing.Acne/developed into white large cluster like lesions was not recovered/not resolved/ongoing.Ooze white to clear stringy material was not recovered/not resolved/ongoing.Lost fingernails/lost a toenail was not recovered/not resolved/ongoing.Scarring was not recovered/not resolved/ongoing.Self mutilating behavior was not recovered/not resolved/ongoing.Nausea was not recovered/not resolved/ongoing.Headaches was not recovered/not resolved/ongoing.Copd was not recovered/not resolved/ongoing.Sleep apnea was not recovered/not resolved/ongoing.Right eye drains thick fluid was not recovered/not resolved/ongoing.Drools nightly thick bloody fluid sometimes white fluid was not recovered/not resolved/ongoing.Hair loss was not recovered/not resolved/ongoing.Pain was not recovered/not resolved/ongoing.Fluid around the heart was not recovered/not resolved/ongoing.Confusion was not recovered/not resolved/ongoing.Sculptra has spread all over the inside of body was unknown.Excess bodily fluid was not recovered/not resolved/ongoing.

Manufacturer Narrative

Company comment: the serious expected event of nerve injury and the non-serious unexpected event of dysgeusia were considered not assessable due to the limited information and a causal relationship to the treatment cannot be ruled out.Serious criteria include permanent damage.Potential root cause include facial nerve injury during the treatment procedure, which led to dysgeusia.An alternative root cause for the nerve injury could be the concomitant liposuction.Potential contributory factor include injection technique.The non-serious events of acne pustular, discharge, onychomadesis, scar, intentional self-injury, nausea, headache, chronic obstructive pulmonary disease, sleep apnoea syndrome, eye discharge, oedema, drooling, alopecia, pain, device dislocation, pericardial effusion and confusional state were considered unexpected and unrelated to the treatment.Alternative root cause include concomitant liposuction for the facial events, and undisclosed or undiagnosed medical conditions.The case meets the criteria for expedited reporting to the regulatory authorities.Product note: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventative action: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 06-oct-2021 by a 61-year-old female patient, who reports her own case.Additional information was received on (b)(6)2021 from the patient herself and on (b)(6) 2021 from the injecting hcp.No information about medical history, history of allergies or previous filler treatments has been provided.The patient's father had alzheimer's.Concomitant treatments included vitamin d3 [vitamin d3], prednisone [prednisone] 5mg daily, biotene [fluorine;xylitol] spiriva respimat [tiotropium bromide monohydrate], citalopram [citalopram], furosemide [furosemide] 20 mg daily, doxycycline [doxycycline] 100mg, alprazolam [alprazolam] 1mg daily, ropinirole [ropinirole] and ondansetron [ondansetron], percocet [oxycodone hydrochloride, oxycodone terephthalate, paracetamol] and ms contin [morphine sulfate] 30 mg.On an unknown date in 2009, the patient had face lift, periorbital chemical peel, lip lift and received treatment with sculptra to both cheeks (unknown amount, lot number, injection technique and needle type).On an unknown date in (b)(6) 2009, the patient visited a physician for lipo-suction of lower face.After reviewing her medical records, physician confirmed that her preoperative and postoperative course was relatively uneventful.On an unknown date between (b)(6) 2009 and (b)(6) 2010, the patient reported that she saw the hcp for follow-up and had developed an intermittent sensation of sour taste(dysgeusia) when eating and the hcp had denied anything to do with the procedure.The patient reported that at a later appointment, another hcp identified the sour taste sensation as no bite syndrome caused by nerve damage (nerve injury).The patient further reported that in (b)(6) 2010, the patient noticed acne/developed into white large cluster like lesions (acne pustular) to her jawline.The acne had moved to her left cheek and developed into white large cluster like lesions that would ooze white to clear stringy material(discharge).The patient reported that she had to use tweezers to pull the stringy material out and at the ends of the strings there would be a small ball causing the openings to become larger.The lesions moved to the right cheek and then down to her neck, breasts, abdomen, left leg, ankle and toes.She reported that the lesions moved to her right foot and up her right leg then to arms and hands.The patient had lost fingernails/lost a toenail (onychomadesis) due to these lesions forming under the nails and had also lost a toenail.The patient reported that the events were cyclical, lasting over a year for each cycle.The patient reported that she had major scarring (scar) caused by the lesions.The patient had seen 36 different physicians but refused to provide any contact details for any treatment providers and numerous providers had abruptly resigned after caring for her.The hcp reported that in 2016, the patient had begun to post complaints on realself (website).The hcp reported that diagnosis seemed to be self mutilating behavior(intentional self-injury) and was referred to a psychiatrist.Hcp reported that upon reviewing, the systemic complaints were not related to sculptra.The patient had nausea(nausea), headaches(headache), diagnosed with copd(chronic obstructive pulmonary disease) and sleep apnea(sleep apnoea syndrome), right eye drains thick fluid (eye discharge), excess bodily fluid(oedema), drools nightly thick bloody fluid sometimes white fluid (drooling) that the patient believed to be sculptra.She also reported that these lesions had recently appeared on her head causing hair loss (alopecia) and causing pain (pain).The patient reported that at the last hospital visit, she was diagnosed with fluid around the heart (pericardial effusion) and was suffering with some confusion (confusional state).All symptoms were ongoing, none had resolved.The patient reported that sculptra has spread all over the inside of body (device dislocation), was painful and came out in tears, urine and when she coughed.Her quality of life was greatly diminished.The patient complained of widespread excoriations/sores (skin abrasion) throughout her body including face, torso, lower extremities etc.The hcp had never seen such systemic issues in any of the patients.Most of the lesions were remote from where the sculptra was injected.The reporting physician had shared patient photos to experts in dermatology and performed sculptra injections.The patient consulted internal medicine and plastic surgeons.They confirmed that the lesions were not representative of anything even vaguely related to sculptra and the linear nature of the many excoriations were more consistent with an external source such as patient self-mutilation due to the linear directions of the excoriations.According to the reporting hcp, the patient's systemic complaints were unrelated to scultptra treatment.Treatment for the adverse event was not reported.Outcome at the time of the report: nerve damage was not recovered/not resolved/ongoing.Intermittent sensation of sour taste was not recovered/not resolved/ongoing.Acne/developed into white large cluster like lesions was not recovered/not resolved/ongoing.Ooze white to clear stringy material was not recovered/not resolved/ongoing.Lost fingernails/lost a toenail was not recovered/not resolved/ongoing.Scarring was not recovered/not resolved/ongoing.Self mutilating behavior was not recovered/not resolved/ongoing.Nausea was not recovered/not resolved/ongoing.Headaches was not recovered/not resolved/ongoing.Copd was not recovered/not resolved/ongoing.Sleep apnea was not recovered/not resolved/ongoing.Right eye drains thick fluid was not recovered/not resolved/ongoing.Drools nightly thick bloody fluid sometimes white fluid was not recovered/not resolved/ongoing.Hair loss was not recovered/not resolved/ongoing.Pain was not recovered/not resolved/ongoing.Fluid around the heart was not recovered/not resolved/ongoing.Confusion was not recovered/not resolved/ongoing.Sculptra has spread all over the inside of body was unknown.Excess bodily fluid was not recovered/not resolved/ongoing.Excoriations/sores was unknown.Tracking list: v.0 initial v.1 fu received on (b)(6) 2021 from physician via hcp.Case was medically confirmed.Event (skin abrasion) added.Concomitant cosmetic procedures, medications, suspect device implant date, reporter causality and narrative were updated.

Manufacturer Narrative

Company comment:the serious expected event of nerve injury and the non-serious unexpected event of dysgeusia were considered not assessable due to the limited information and a causal relationship to the treatment cannot be ruled out.Serious criteria include permanent damage.Potential root cause include facial nerve injury during the treatment procedure, which led to dysgeusia.An alternative root cause for the nerve injury could be the concomitant liposuction.Potential contributory factor include injection technique.An alternative root cause for dysgeusia could be the concomitant medication the non-serious events of acne pustular, discharge, onychomadesis, scar, intentional self-injury, nausea, headache, chronic obstructive pulmonary disease, sleep apnoea syndrome, eye discharge, oedema, drooling, alopecia, pain, device dislocation, pericardial effusion, skin abrasion and confusional state were considered unexpected and unrelated to the treatment.Alternative root cause include concomitant liposuction for the facial events, intentional self-injury for skin abrasion, and undisclosed or undiagnosed medical conditions.The case meets the criteria for expedited reporting to the regulatory authorities.Product note:routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventative action: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

• Brand Name: SCULPTRA AESTHETIC
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 north freeway; fort worth, TX 76177
• MDR Report Key: 12759718
• MDR Text Key: 281739971
• Report Number: 9710154-2021-00068
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030050S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALPRAZOLAM 1 MG DAILY; ALPRAZOLAM 1 MG DAILY; BIOTENE [FLUORINE,XYLITOL]; BIOTENE [FLUORINE,XYLITOL]; CITALOPRAM; CITALOPRAM; DOXYCYCLINE 100 MG; DOXYCYCLINE 100 MG; FUROSEMIDE 20 MG DAILY; FUROSEMIDE 20 MG DAILY; HYDROXYZINE; MORPHINE SULFATE 30 MG; MORPHINE SULFATE 30 MG; MS CONTIN; ONDANSETRON; ONDANSETRON; PERCOCET [OXYCODONE HYDROCHLORIDE,OXYCODONE TEREPH; PREDNISONE 5 MG DAILY; PREDNISONE 5 MG DAILY; ROPINIROLE; ROPINIROLE; SPIRIVA RESPIMAT [TIOTROPIUM BROMIDE MONOHYDRATE]; SPIRIVA RESPIMAT [TIOTROPIUM BROMIDE MONOHYDRATE]; VITAMIN D3; VITAMIN D3
• Patient Outcome(s): Other; Disability
• Patient Age: 61 YR
• Patient Sex: Female