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

Lot Number 17319

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

Patient Problems Abscess (1690); Cellulitis (1768); Cyst(s) (1800); Purulent Discharge (1812); Discomfort (2330); Skin Infection (4544); Swelling/ Edema (4577)

Event Date 01/17/2022

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2022 by an other health professional concerning a (b)(6) female patient.The patient was not pregnant.The patient had no known allergies.No information about medical history or previous filler treatments has been provided.Concomitant treatments included oral protonix [omeprazole].On (b)(6) 2022, the patient received treatment with 1 ml restylane silk (lot 17319) to upper lip, 2 ml restylane lyft with lidocaine (lot 19673 and 19107),1 ml to each side of cheek and 1 ml restylane defyne (lot 19267) to left nasolabial fold with unknown injection technique and needle type.The patient also received juvederm brand filler to right nasolabial fold on the same day.In (b)(6) 2022, the patient experienced an extensive/massive reaction; facial cellulitis (implant site cellulitis) and facial swelling (implant site swelling).On (b)(6) 2022, the patient reported the events to the hcp.On (b)(6) 2022, the patient received first dose of iv daptomycin [daptomycin] antibiotics and received subsequent iv daptomycin doses from (b)(6) 2022 to present.On (b)(6) 2022, the patient was hospitalized at a medical center.On (b)(6) 2022, the patient will be discharged for surgical incision and drainage.Outcome at the time of the report: cellulitis was not recovered/not resolved/ongoing.Swelling was not recovered/not resolved/ongoing.

Manufacturer Narrative

Evaluation text: 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 non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Capa comment: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Company comment: the serious expected events of cellulitis and swelling at implant site were considered possibly related to the treatments.Serious criteria include the need for medical intervention and hospitalization to prevent permanent damage.The potential root cause include treatment procedure.The case meets the criteria for expedited reporting to the regulatory authorities.

Manufacturer Narrative

Evaluation text: 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.Capa comment: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Company comment: the serious events of abscess, infection and cellulitis at implant site, and the non-serious events of oedema and inflammation at implant site, discomfort at injection site and purulent discharge were considered expected and possibly related to the treatments.The serious event of cyst at implant site was considered expected and possibly related to the treatment with restylane silk and unexpected, unrelated to the treatments with restylane defyne and restylane lyft with lidocaine as no treatment was performed to the affected area.Serious criteria include the need for multiple medical and surgical interventions and hospitalization to prevent permanent damage.The potential root cause include injection procedure associated with inadequate aseptic technique and post-injection infection treatment.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 27-jan-2022 by a registered concerning a 71-year-old female patient.The patient's medical history included psoriasis and acid reflux.Concomitant treatments included oral protonix [omeprazole].The patient had no known allergies.No information about previous filler treatments has been provided.In (b)(6) 2021, the patient received moderna covid-19 vaccine.On (b)(6) 2022, the patient received treatment with 1 ml restylane silk (lot 17319) to upper lip, 2 ml restylane lyft with lidocaine (lot 19673, 19107),1 ml to each side of cheek and malar region and 1 ml restylane defyne (lot 19267) to left nasolabial fold with unknown injection technique and needle type.The patient also received juvederm ultra plus xc to right nasolabial fold on the same day.In (b)(6) 2022 (approximately 1 week after injection), the patient noticed initial inflammation (implant site inflammation) involving the upper lip and left malar area and self-medicated with amoxicillin [amoxicillin].There was no improvement.On (b)(6) 2022, patient presented with inflamed upper lip cyst (implant site cyst) which underwent incision and drainage.Also there was swelling/fullness/edema (implant site oedema) in left malar area and slight discomfort (injection site discomfort) with no evidence of associated cellulitis.The patient was placed on bactrim [sulfamethoxazole, trimethoprim] with limited improvement.On (b)(6) 2022, the patient was seen in hcp office and the attempted incision and drainage of the left malar area fullness was unsuccessful with limited drainage.The patient was referred to the emergency room and at that time patient was placed on iv clindamycin [clindamycin] for 1 dose and discharged after ct scan showed left facial cellulitis (implant site cellulitis), no evidence of abscess, however, showed inflammation.On (b)(6) 2022, the patient received first dose of iv daptomycin [daptomycin] antibiotics and received subsequent iv daptomycin doses from (b)(6) 2022 to present.The patient continued worsening of the swelling and edema and was placed on zyvox [linezolid] on (b)(6) 2022 and also had hyaluronidase [hyaluronidase] injections of the right malar and upper lip area to remove the product.On (b)(6) 2022, the patient was seen by infectious disease hcp and placed on iv antibiotics.An ultrasound was also ordered which showed a fluid collection on the bilateral malar regions.The patient also had impending skin breakdown in the nasolabial fold.On (b)(6) 2022, the patient underwent limited incision and drainage of these areas on the left side with associated washout in the hcp office.The patient at that time was encouraged to be admitted to the hospital for iv antibiotics and formal washout in the operating room.The patient refused admission at that time and she was going to report to the emergency room on (b)(6) 2022 morning.On (b)(6) 2022, the patient was admitted for iv antibiotics, formal washout, incision and drainage.The patient was diagnosed with bilateral multiple deep subcutaneous malar abscesses (implant site abscess) and multiple superficial abscesses of the upper lip region.The potential risks, benefits and complications of surgery were discussed.The patient understood the associated risks and complications and agreed to proceed with procedure.The patient was marked and then brought into the operating room, laid supine in the operating table.The patient was placed under an lma anesthesia and the facial region was then prepped and draped in the usual standard fashion with ophthalmic betadine [povidone-iodine] solution.The patient then underwent incision in the multiple areas.The previous incision sites were also sharply debrided and limited blunt dissection was performed to avoid trauma to any facial muscles or nerves.The prulent fluid (purulent discharge) was expressed and then extensive washout was performed in the left area with antibiotic solution containing gentamicin [gentamicin] and vancomycin [vancomycin] and approximately 3 liter of fluid was used to irrigate out these areas.In addition to this, a small incision was made in the right cheek region and a purulent fluid was also expressed and a small incision was made in the nasolabial fold area to allow for adequate drainage.Multiple small subcutaneous abscesses were also drained in the upper lip region, and these were also washed out extensively with the antibiotic normal saline [normal saline] solution.A total of 3 liter of antibiotic normal saline solution was used to irrigate out these areas.Following adequate irrigation and clear fluid, the patient had penrose drains placed in the malar deep areas to allow for adequate drainage.The patient had packing placed in the upper lip regions and then the patient had sterile dressings placed.The patient was then extubated and transferred from the or to the recovery room in stable condition.The patient would be discharged home when the infection (implant site infection) appears to be under control, packing removed, stable tolerating diet, ambulating and voiding with adequate pain.Also, informed that she would be admitted for further iv antibiotics for further evaluation.Outcome at the time of the report: abscesses was unknown.Cellulitis was not recovered/not resolved/ongoing.Inflammation was unknown.Infection was unknown.Cyst was unknown.Swelling/fullness/edema was not recovered/not resolved/ongoing.Discomfort was unknown.Purulent fluid was unknown.Tracking list: v.0: initial.V.1: fu1 information was received on 22-feb-2022 from other hcp.Events (implant site abscess, infection, inflammation, cyst, purulent discharge and injection site discomfort) added.Coding and verbatim of event implant site oedema updated.Patient medical history, covid-19 vaccine, even severity, reporter causality, corrective treatment details and lab investigations were updated.

• Brand Name: RESTYLANE SILK
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 13546768
• MDR Text Key: 290393408
• Report Number: 1000118068-2022-00002
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/17/2022,03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Lot Number: 17319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2022
• Distributor Facility Aware Date: 02/22/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JUVEDERM; JUVEDERM; PROTONIX [OMEPRAZOLE]; PROTONIX [OMEPRAZOLE]; RESTYLANE DEFYNE; RESTYLANE DEFYNE; RESTYLANE LYFT WITH LIDOCAINE; RESTYLANE LYFT WITH LIDOCAINE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female