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

Lot Number UNKNOWN

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

Patient Problems Abscess (1690); Purulent Discharge (1812); Ecchymosis (1818); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Deformity/ Disfigurement (2360); Subcutaneous Nodule (4548)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious events of mass at implant site and cutaneous contour deformity, and the non-serious events of bruising at implant site and purulent discharge were considered expected and possibly related to the treatment.Restylane lyft with lidocaine was used off label under the orbital rim.Serious criteria include the need for multiple medical interventions including antibiotics, steroids, incision and drainage.The cutaneous contour deformity had been treated with repeated saline injections.It was unclear if the cutaneous contour deformity would result in permanent damage since the event was still ongoing and the baseline status of the affected area was not provided.Potential etiologies include infection with chronic inflammatory reaction.Potential contributory factors for inflammatory reaction and bruising include inflammation and vasculitis associated with her underlying rheumatoid arthritis (ra) and continued presence of the implant.The chronic use of a concomitant nsaid might have also contributed to the chronic bruising.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 comment: lot number was not reported.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 21-aug-2020 by a (b)(6)-year-old female patient concerning about herself.Additional information was received on 24-aug-2020 from same reporter.The patient medical history included rheumatoid arthritis since the age of 19 and was currently in remission at this time and was not on immunosuppressives at the time of injection.Concomitant treatments included meloxicam [meloxicam], 15 mg q day and vitamins, unspecified [vitamins nos].The patient had previously received treatment with juvederm and botox.On an unknown date in (b)(6) 2020, the patient received treatment with 2 syringes restylane lyft with lidocaine to bilateral cheek bone, under eye socket bone and sides of mouth (unknown amount, needle type and injection technique).The restylane lyft with lidocaine was injected under eye socket bone (off label use of device).One week later, on an unknown date in 2020, the patient had suffered a horrible reaction that had been going on for over 6 months.The patient had experienced boil type bumps/lump/large marble popped up(implant site mass) on face.The patient was visiting her hcp once a week, who would drain with blade pus and blood would come out(purulent discharge).The patient was put on unspecified oral antibiotics, oral steroids 20 mg for 10 days and injected a few times with cortisone [cortisone].On an unknown date in 2020, it was reported that the drainage was sent to pathology, no bacteria or infection were found.Now, patient still had a pretty big lump on the left side of her mouth, which subsided a little bit.The patient also had right cheek area sunken/cheek has a caved in spot(cutaneous contour deformity) on side of face.She had been receiving saline [sodium chloride] injections to puff it up, last treatment was 4 days ago, and it was helping.The patient also had permanent bruising(implant site bruising).Events were ongoing.Outcome at the time of the report: boil type bumps/lump/large marble popped up was not recovered/not resolved.Pus and blood would come out was not recovered/not resolved.Permanent bruising was not recovered/not resolved.Right cheek area sunken/cheek has a caved in spot was not recovered/not resolved.Restylane lyft with lidocaine was injected under eye socket bone was recovered/resolved.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 21-aug-2020 by a 67-year-old female patient.Additional information was received on 24-aug-2020 from same reporter.The patient medical history included autoimmune disease rheumatoid arthritis (many years ago), multiple skin cancers (several years ago), multiple joint replacements and breast implants.The patient had previously received treatment with dysport, botox, juvederm and restylane silk.Concomitant treatments included meloxicam [meloxicam], 15 mg q day and vitamins, unspecified [vitamins nos].The patient was not taking any routine medications or products since her last injection on (b)(6) 2020 but at the time of her injection on (b)(6) 2019, she was routinely taking remicade [remicade] and prednisone [prednisone].On (b)(6) 2019, the patient received treatment with 1 ml restylane lyft with lidocaine to bilateral zygomatic arches, nasolabial folds and corners of the mouth with unknown needle type and injection technique.On an unknown date in (b)(6) 2019, about a week or 2 after injection, patient experienced a little inflammatory(implant site inflammation) and mild infection(implant site infection) for which she was treated with anitbiotics and possibly with incision and drainage (i and d).On an unknown date in 2019, the infection and inflammation were resolved.On (b)(6) 2020, the patient received treatment with 2 ml restylane lyft with lidocaine to bilateral zygomatic arches, nasolabial folds and corners of the mouth with unknown needle type and injection technique.Unknown time later, on an unknown date in (b)(6) 2020, patient developed recurrent tender (implant site pain), inflammatory(implant site inflammation) boil type bumps/lump/large marble popped up/cystic nodules (implant site nodule) that when lanced pus and blood would come out(purulent discharge), and recurrent abscesses(implant site abscess) to both nasolabial folds and zygomas.The patient also had multiple right cheek area sunken/cheek has a caved in spot/multiple atrophic areas (cutaneous contour deformity) areas to zygomas.The patient was put on unspecified oral antibiotics, oral steroids 20 mg for 10 days and injected a few times with cortisone [cortisone].On an unknown date in 2020, it was reported that the drainage was sent to pathology, twice, no bacteria or infection were found.On an unknown date in 2020, the patient had also undergone i and d and irrigating with saline [sodium chloride].She was also prescribed with oral antibiotics, injected with keflex [cefalexin] and cefazolin [cefazolin]; bactrim [sulfamethoxazole, trimethoprim] and levaquin [levofloxacin].The patient still had the atrophic areas to zygomas, abscesses and the tender inflammatory cystic nodules to the areas injected and were recurrent.Outcome at the time of the report: infection was recovered/resolved.Inflammatory was not recovered/not resolved.Abscesses was not recovered/not resolved.Boil type bumps/lump/large marble popped up/cystic nodules was not recovered/not resolved.Right cheek area sunken/cheek has a caved in spot/multiple atrophic areas was not recovered/not resolved.Pus and blood would come out was not recovered/not resolved.Permanent bruising was not recovered/not resolved.Tender was not recovered/not resolved.Tracking list: v.0 initial.V.1 fu received on 21-sep-2020 and 22-sep-2020 from the physician.Case was medically confirmed.Events (abscess, pain, inflammation, infection at implant site) added.Coding of event mass at implant site changed to nodule at implant site.Event off label use of device deleted.Patient medical history, past filler treatment, concomitant medications, suspect device implant date, location, volume and corrective treatment details were updated.

Manufacturer Narrative

Pharmacovigilance comment: the serious events of infection, inflammation, abscess, nodule at implant site and cutaneous contour deformity and the non-serious events of bruising, pain at implant site and purulent discharge were considered expected and possibly related to the treatment.Serious criteria include the need for multiple medical, surgical interventions including antibiotics, steroids, incision and drainage.The cutaneous contour deformity had been treated with repeated saline injections.It was unclear if the cutaneous contour deformity would result in permanent damage since the event was still ongoing and the baseline status of the affected area was not provided.Potential etiologies include infection with chronic inflammatory reaction.Potential contributory factors for inflammatory reaction and bruising include inflammation and vasculitis associated with her underlying rheumatoid arthritis and continued presence of the implant.The chronic use of a concomitant nsaid might have also contributed to the chronic bruising.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 comment: lot number was not reported.

• Brand Name: RESTYLANE LYFT WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• MDR Report Key: 10509297
• MDR Text Key: 206305691
• Report Number: 1000118068-2020-00034
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2020
• Distributor Facility Aware Date: 09/21/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MELOXICAM; MELOXICAM; PREDNISONE(PREDNISONE); REMICADE(INFLIXIMAB); VITAMINS, UNSPECIFIED; VITAMINS, UNSPECIFIED
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR