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Lot Number A4077
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ecchymosis (1818); Granuloma (1876); Subcutaneous Nodule (4548); Swelling/ Edema (4577)
Event Date 04/01/2015
Event Type  Injury  
Manufacturer Narrative
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. The reported lot number was valid and verified the reported product. The information in this case does not indicate a nonconforming product or malfunction. Investigations including documentation review of the analysis certificate at release step of sculptra batch a4077 has been re-checked and all the results complied with specifications. Moreover, both the supplier certificate of analysis and the internal certificate of analysis relevant to the lots of blanose cmc (code (b)(4) batch an103865), plla (code (b)(4) batch an112003) and mannitol (code (b)(4) batch an106983) utilized in the manufacturing of sculptra batch a4077 have been re-controlled and all the results were conforming with the specifications limits. We have re-checked also the batch record of sculptra lot a4077; no anomalies impacting the quality of the product released for the market were identified. The performed investigation are therefore considered adequate and no additional investigations will be conducted. Company comment: the serious events of mass, swelling at implant site, granuloma skin and the non-serious event of bruising at implant site were considered expected and possibly related to the treatment. Serious criteria include the need for multiple medical interventions and long standing events suggestive of permanent damage. Potential root causes include treatment procedure or a foreign body reaction to the product in the local tissue. The case meets the criteria for expedited reporting to the regulatory authorities.
Event Description
Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2015 by a (b)(6) female patient, concerning herself. No information about medical history, concomitant medication, history of allergies or previous filler treatments has been provided. On (b)(6) 2014, the patient received treatment with 3 vials sculptra aesthetic (lot a4077) to the cheeks and area around the eyes with unknown injection technique and needle type. Unknown time later, on an unknown date in (b)(6) 2015, the patient experienced harder lumps (implant site mass) and swelling (implant site swelling). On (b)(6) 2015, the patient reported that she thinks the physician injected her immediately after reconstitution rather than allow the product to hydrate over 2 hours. On (b)(6) 2015, the patient called back and stated that the lumps were worse. The patient still felt the lumps underneath her skin where she was injected and currently, there were more lumps. She also said the lumps were harder. The patient stated she was bruised (implant site bruising) for about 1 month after the injection as well. The patient would be following up with her doctor on (b)(6)2015. As per follow up report received on (b)(6) 2015, the patient reported she had applied cold compress to alleviate symptoms of the events. The patient contacted their health care provider on an unspecified date and received [triamcinolone acetonide] injections. At the time of the report the patient had not recovered. As per follow up report received on (b)(6) 2021, the patient reported that she had seen approximately 25 doctors since 2014 to treat her granulomas (granuloma skin) with massage, saline [sodium chloride], kenalog and 5-fu [5-fu] but nothing has helped. There had been minimal improvements. Outcome at the time of the report: harder lumps was not recovered/not resolved/ongoing. Swelling was not recovered/not resolved/ongoing. Granulomas was not recovered/not resolved/ongoing. Bruised was recovered/resolved. Tracking list: v. 0 initial v. 1 fu received on (b)(6) 2015 from the patient. Concerning dosage and administration and reconstitution of the product and narrative was updated. V. 2 fu received on (b)(6) 2015 from the patient. Events harder and bruised were added and narrative was updated. V. 3 fu received on (b)(6) 2015 from the patient. Volume of sculptra aesthetic and narrative was updated. V. 4 fu received on (b)(6) 2015 from the patient. The dosage, implant site date, device location of sculptra aesthetic was updated. The adverse event swelling was added. The corrective treatment cold compress to alleviate symptoms of the events and kenalog injections and outcome of the events were updated. V. 5 fu received on (b)(6) 2021 from the patient. Case upgraded to serious. Event (granulomas) added. Verbatim of lumps updated to harder lumps. Corrective treatments saline and 5fu were added.
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Manufacturer (Section D)
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
MDR Report Key12319663
MDR Text Key267263264
Report Number1000118068-2021-00024
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberA4077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/13/2021
Distributor Facility Aware Date07/21/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer07/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/13/2021 Patient Sequence Number: 1