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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALDERMA Q-MED SCULPTRA AESTHETIC; IMPLANT, DERMAL, FOR AESTHETIC USE
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GALDERMA Q-MED SCULPTRA AESTHETIC; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Scarring (2061); Discharge (2225); Ulcer (2274); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Pharmacovigilance comment: the serious events of scarring and ulcers at the implant site were considered expected and possibly related to the treatment.Serious criteria include permanent damage.The non-serious events of mass and discharge at the implant site were considered expected and possibly related to the treatment.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.Manufacturer narrative: lot number was not reported.(b)(4).
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2019 by a (b)(6) female consumer, who reported her own case.The patient's medical history included depression.The patient had no history of allergies.No information about concomitant medication has been provided.The patient had previously received filler treatment with restylane to lips on (b)(6) 2017.On (b)(6) 2017, the patient received treatment with sculptra aesthetic to upper cheeks (unknown amount, lot number, injection technique and needle type).The patient massaged after the injection as instructed.On an unknown date, after the treatment, the patient experienced scars(implant site scar) and open sores(implant site ulcer) at face (on the pictures they were localized on cheek and jaw area).The patient reported there were white bumps (implant site mass) that sometimes opened up and white stuff comes out (implant site discharge) out of the opening.Sometimes the bumps were hard.The patient provided pictures of her condition, taken on (b)(6) 2018 and (b)(6) 2019.The patient reporter that prior to the sculptra injection her skin was fine.Outcome at the time of the report: scars was not recovered/not resolved.Open sores was not recovered/not resolved.Bumps was not recovered/not resolved.White stuff comes out was not recovered/not resolved.
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on (b)(6)2019 by a 67-years old female consumer, who reported her own case.The patient's medical history included depression and allergy to pcn.Concomitant medication included cymbalta [cymbalta].The patient had previously received treatment with restylane on(b)(6)2017, restylane silk to lips on (b)(6)2017 and juvederm ultra plus xc to marionette lines and oral commissures on 19-jan-20??.On (b)(6)2017, the patient received treatment with sculptra aesthetic with lidocaine to malar and submalar area with 25gx 1½ needle and fanning technique.The patient massaged after the injection as instructed.On (b)(6)2017, the patient received treatment with sculptra aesthetic with lidocaine to malar and submalar area with 25gx 1½ needle and fanning technique.On (b)(6)2017, the patient received treatment with sculptra aesthetic with lidocaine to malar and submalar area with 25gx 1½ needle and fanning technique.On (b)(6)2017, the patient received treatment with sculptra aesthetic with lidocaine to malar and submalar area with 25gx 1½ needle and fanning technique.No lot numbers were provided for the provided treatments.On an unknown date, after the treatment(s), the patient experienced scars(implant site scar) and open sores(implant site ulcer) at face (on the pictures they were localized on cheek and jaw area).The patient reported there were white bumps(implant site mass) that sometimes opened up and white stuff comes out(implant site discharge) out of the opening.Sometimes the bumps were hard.The patient provided pictures of her condition, taken on(b)(6)2018 and (b)(6)2019.The patient reporter that prior to the sculptra injection her skin was fine.On (b)(6)2019, the patient e-mailed and reported that she met her personal physician on(b)(6)2019.He made a referral for a dermatologist.The patient attended the scheduled appointment on (b)(6)2019.There were several avenues she could take.The patient had not made up her mind, at that time, as to what avenue she will pursue.She reported that she have dealt with this for over a year and she knew that it was the sculptra that has migrated(device dislocation) and lesions appeared.There was a grainy substance in those lesions.There was no doubt in her mind that it was the sculptra that caused her facial condition.On (b)(6)2019, follow-up information including patient photos (taken at the day of reporting, (b)(6)2019) were received from the reporting patient.The patient reported that around each one of the lesions, were multiple bumps that eventually were to come out to the surface.The patient was seeing the dermatologist again on (b)(6)2019.The patient believed it was going to take some time, with a dermatologist, to reduce any scars and clear up the lesions.On (b)(6)2019, follow-up information was provided from the clinic including patient photos.The aesthetic director reported that the patient never called them or contacted them regarding any problems or adverse reactions.The clinic sent photos.Apparently, the patient had four treatment sessions with sculptra and not one as the patient had reported.The onset date of the events were still unknown.Outcome at the time of the report: scars was not recovered/not resolved.Open sores was not recovered/not resolved.Bumps was not recovered/not resolved.White stuff comes out was not recovered/not resolved.Sculptra that has migrated was unknown.Tracking list: v.0 initial, v.1 fu received on (b)(6)2019: added event of device dislocation.Outcome is still not recovered.Patient photos were provided.V.2 fu received on(b)(6)2019: patient records from the clinic were provided including patient photos.Added additional suspect treatments, dob, allergies, concomitant medication and past treatments.
 
Manufacturer Narrative
Pharmacovigilance comment: the serious events of scarring and ulcers at the implant site were considered expected and possibly related to the treatment.Serious criteria include permanent damage.The non-serious events of mass and discharge at the implant site and device dislocation were considered expected and possibly related to the treatment.Potential contributory factors include past filler treatments.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.Manufacturer narrative: lot number was not reported.Exemption information: galderma laboratories l.P.Is submitting this report on behalf of q-med ab.Exemption number (b)(4).
 
Manufacturer Narrative
Pharmacovigilance comment: the serious events of scarring and ulcers at the implant site were considered expected and possibly related to the treatment.Serious criteria include permanent damage.The non-serious events of mass and discharge at the implant site and device dislocation were considered expected and possibly related to the treatment.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.Manufacturer narrative: lot number was not reported.Exemption information: galderma laboratories l.P.Is submitting this report on behalf of q-med ab.Exemption number (b)(4).
 
Event Description
Case reference number (b)(4) is a spontaneous report sent on (b)(6)2019 by a 67-years old female consumer, who reported her own case.The patient's medical history included depression.The patient had no history of allergies.No information about concomitant medication has been provided.The patient had previously received filler treatment with restylane to lips on (b)(6)2017.On (b)(6)2017, the patient received treatment with sculptra aesthetic to upper cheeks (unknown amount, lot number, injection technique and needle type).The patient massaged after the injection as instructed.On an unknown date, after the treatment, the patient experienced scars(implant site scar) and open sores(implant site ulcer) at face (on the pictures they were localized on cheek and jaw area).The patient reported there were white bumps(implant site mass) that sometimes opened up and white stuff comes out(implant site discharge) out of the opening.Sometimes the bumps were hard.The patient provided pictures of her condition, taken on (b)(6)2018 and (b)(6)2019.The patient reporter that prior to the sculptra injection her skin was fine.On (b)(6)2019, the patient e-mailed and reported that she met her personal physician on(b)(6)2019.He made a referral for a dermatologist.The patient attended the scheduled appointment on (b)(6)2019.There were several avenues she could take.The patient had not made up her mind, at that time, as to what avenue she will pursue.She reported that she have dealt with this for over a year and she knew that it was the sculptra that has migrated(device dislocation) and lesions appeared.There was a grainy substance in those lesions.There was no doubt in her mind that it was the sculptra that caused her facial condition.On(b)(6)2019, follow-up information including patient photos (taken at the day of reporting, 01-apr-19) were received from the reporting patient.The patient reported that around each one of the lesions, were multiple bumps that eventually were to come out to the surface.The patient was seeing the dermatologist again on (b)(6)2019.The patient believed it was going to take some time, with a dermatologist, to reduce any scars and clear up the lesions.Outcome at the time of the report: scars was not recovered/not resolved.Open sores was not recovered/not resolved.Bumps was not recovered/not resolved.White stuff comes out was not recovered/not resolved.Sculptra that has migrated was unknown.Tracking list: v.0 initial, v.1 fu received on(b)(6)2019: added event of device dislocation.Outcome is still not recovered.Patient photos were provided.
 
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Brand Name
SCULPTRA AESTHETIC
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 Key8367108
MDR Text Key137046659
Report Number9710154-2019-00002
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P030050/S2
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 04/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CYMBALTA
Patient Outcome(s) Disability;
Patient Age67 YR
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