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

Lot Number 19548

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

Patient Problems Abscess (1690); Cellulitis (1768); Skin Infection (4544); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious events of cellulitis, abscess, inflammation, infection at implant site and the non-serious event of oedema at implant site were considered expected and possibly related to the treatments.Serious criteria include the need for surgical and multiple medical interventions and hospitalization to prevent permanent damage.Potential root cause include injection procedure associated with inadequate aseptic technique.Potential contributory factor or alternative root cause of the events include past treatment with pmma, as reactivation of pmma inflammation was indicated in the received case report.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: restylane kysse-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.No potential quality issues have been identified in the manufacturing process of the specified batch.The batch is manufactured and released according to symatese quality management system.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.Restylane-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.No potential quality issues have been identified in the manufacturing process of the specified batch.The batch is manufactured and released according to galderma quality management system.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.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 13-dec-2021 by a physician, which refers to a (b)(6) caucasian male patient.No information about medical history, concomitant medication or history of allergies had been provided.The patient had previously received treatment with pmma [polymethylmethacrylate].Treatment date and location were not reported.On (b)(6) 2021, the patient received treatment with 1 ml of restylane kysse (lot s2202870006) to lips using cannula 25g and needle with retro-injection technique.On (b)(6) 2021, the patient received treatment with 2 ml restylane (lot 19548), 0.5 ml on each side of pyriform sinus and 0.5 ml in each side of dark circles, using cannula 25 g (in dark circles) and needle (in dark circles and pyriform sinus) with bolus technique in pyriform sinus and retro-injection technique in dark circles.On (b)(6) 2021, the patient experienced important ipsilateral edema (implant site oedema), reactivation of pmma [polymethylmethacrylate] inflammation (implant site inflammation) from past procedures and infection (implant site infection) at the right region of the nasolabial sulcus.On an unknown date in (b)(6) 2021, the patient also experienced cellulitis (implant site cellulitis) and abscess (implant site abscess).On (b)(6) 2021, the patient underwent following lab test: complete blood count (result: 15,890/mm) and sinus tomography which showed the presence of exogenic and asymmetric material at subcutaneous hemifaces and an acute inflammatory process could not be excluded.As a corrective treatment, the patient received the prescription of prednisolone and dipyrone and had difficulty to buy these medications (use of dypirone was not mentioned).In (b)(6) 2021, the patient had received additional corrective treatments with clavulin [amoxicillin sodium, clavulanate potassium], cefalexin [cefalexin], paco [codeine phosphate, paracetamol], nimesulide [nimesulide] and prednisolone [prednisolone].On (b)(6) 2021, a drainage was performed in a hospital environment besides treatment with medications.On (b)(6) 2021, the patient was hospitalized to perform a new tomography as the previous one had only shown signs of acute inflammation.However, the patient refused to provide the result of the second tomography to the reporter.At the time of report, the patient was still hospitalized.The events intensity was assessed as serious by reporter.The causal relationship between restylane kysse and restylane and all reported events was reported as possible.Outcome at the time of the report cellulitis was not recovered/not resolved/ongoing.Abscess was not recovered/not resolved/ongoing.Inflammation was not recovered/not resolved/ongoing.Infection was not recovered/not resolved/ongoing.Edema was not recovered/not resolved/ongoing.Tracking list: v.0 initial.V.1 fu received on (b)(6) 2021 from another physician: events (implant site inflammation and infection) added.Patient demographics, past filler treatment, suspect device implant date, location, volume, needle type, injection technique, hospitalization details, outcome, reporter causality, corrective treatments and laboratory test details were added.Brr results were received.

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2021 by a physician, which refers to a 36-year-old caucasian male patient.No information about medical history or history of allergies had been provided.The patient had previously received treatment with pmma [polymethylmethacrylate] by another healthcare professional in (b)(6) 2021.The injection sites were the nasolabial area, chin, jaw and zygoma.On (b)(6) 2021, the patient received treatment with 1 ml of restylane kysse (lot s2202870006) to lips using cannula 25g and needle with retro-injection technique.The reporter confirmed that the patient did not experience any adverse events in lips.On (b)(6) 2021, the patient received treatment with 2 ml restylane (lot 19548), 0.5 ml on each side of pyriform sinus and 0.5 ml in each side of dark circles, using cannula 25 g (in dark circles) and needle (in dark circles and pyriform sinus) with bolus technique in pyriform sinus and retro-injection injection technique in dark circles.On (b)(6) 2021, the patient experienced important ipsilateral edema (implant site oedema), reactivation of pmma [polymethylmethacrylate] inflammation (implant site inflammation) from past procedures and infection (implant site infection) at the right region of the nasolabial sulcus.On an unknown date in (b)(6) 2021, the patient also experienced cellulitis (implant site cellulitis) and abscess (implant site abscess).On (b)(6) 2021, the patient underwent following lab test: complete blood count (result: 15,890/mm) and sinus tomography which showed the presence of exogenic and asymmetric material at subcutaneous hemifaces and an acute inflammatory process could not be excluded.As a corrective treatment, the patient received the prescription of prednisolone and dipyrone and had difficulty to buy these medications (use of dypirone was not mentioned).In (b)(6) 2021, the patient had received additional corrective treatments with clavulin [amoxicillin sodium, clavulanate potassium], cefalexin [cefalexin], paco [codeine phosphate, paracetamol], nimesulide [nimesulide] and prednisolone [prednisolone].On (b)(6) 2021, a drainage was performed in a hospital environment besides treatment with medications.On (b)(6) 2021, the patient was hospitalized to perform a new tomography as the previous one had only shown signs of acute inflammation.However, the patient refused to provide the result of the second tomography to the reporter.At the time of report, the patient was still hospitalized.The events intensity was assessed as serious by reporter.The causal relationship between restylane and all reported events was reported as possible.Outcome at the time of the report: cellulitis was not recovered/not resolved/ongoing.Abscess was not recovered/not resolved/ongoing.Inflammation was not recovered/not resolved/ongoing.Infection was not recovered/not resolved/ongoing.Edema was not recovered/not resolved/ongoing.Tracking list: v.0 initial; v.1 fu received on 15-dec-2021 from another physician: events (implant site inflammation and infection) added.Patient demographics, past filler treatment, suspect device implant date, location, volume, needle type, injection technique, hospitalization details, outcome, reporter causality, corrective treatments and laboratory test details were added.Brr results were received.V.2 fu received on 28-dec-2021 from the same physician who forwarded the first follow-up (secondary reporter).Past filler implant date and locations were updated.The reporter confirmed that the patient did not experience any adverse events in lips.Hence restylane kysse assessed as concomitant treatment.

Manufacturer Narrative

Company comment: the serious events of cellulitis, abscess, inflammation, infection at implant site and the non-serious event of oedema at implant site were considered expected and possibly related to the restylane treatment.Serious criteria include the need for surgical and multiple medical interventions and hospitalization to prevent permanent damage.Potential root cause include injection procedure associated with inadequate aseptic technique.Potential contributory factor or alternative root cause of the events include past treatment with pmma, as reactivation of pmma inflammation was indicated in the received case report.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: restylane kysse-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.No potential quality issues have been identified in the manufacturing process of the specified batch.The batch is manufactured and released according to symatese quality management system.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.Restylane-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.No potential quality issues have been identified in the manufacturing process of the specified batch.The batch is manufactured and released according to galderma quality management system.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.

• Brand Name: RESTYLANE
• 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 n. freeway; fort worth, TX 76177
• MDR Report Key: 13078434
• MDR Text Key: 288287929
• Report Number: 9710154-2021-00080
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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 Expiration Date: 04/30/2024
• Device Lot Number: 19548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 12/28/2021
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male