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Lot Number 19488
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/07/2022
Event Type  Injury  
Manufacturer Narrative
Company comment: the serious event of infection at implant site and the non-serious events of erythema, pain, and swelling at implant site were considered expected and possibly related to the treatments. Serious criteria include the need for multiple medical interventions to prevent permanent damage. The potential root cause include injection procedure associated with inadequate aseptic technique. Potential contributory factor for the recurrent infection may be corrective treatment non-compliance. The restylane defyne was used off label. The case meets the criteria for expedited reporting to the regulatory authorities. Evalution text: restylane defyne-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. Recommendation for corrective and preventive action: restylane defyne-no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.
Event Description
Case reference number (b)(4) is a spontaneous report sent on 08-mar-2022 by a physician which refers to a female patient of an unknown age. Additional information was received on 09-mar-2022 from same reporter. The patient's medical history included infection. The patient had no known allergies. The patient was not taking any concomitant medications. The patient had previously received treatment with many unspecified fillers for cosmetic purposes. On an unknown date, the patient had received flu vaccine. She was also vaccinated against covid-19 and had received booster dose. The hcp performed health screening 2 weeks prior to the injections and the patient did not have a cold and was not sick prior to the injections. On (b)(6) 2021, the patient received treatment with 1 syringe restylane defyne (lot 19488) to chin and piriform area and 1 syringe restylane lyft with lidocaine (lot 19423) to cheek and jawline (unknown injection technique and needle type). The restylane defyne was injected to piriform area (off label use of device). On (b)(6) 2021, the patient received treatment with 1 syringe restylane lyft with lidocaine (lot 19423) to cheeks with unknown injection technique and needle type. On (b)(6) 2022, the patient called hcp and reported that she noticed red (implant site erythema) and tenderness (implant site pain) on the left cheek. The hcp called her to office but patient could not visit hcp office on that day. The hcp had prescribed her doxycycline [doxycycline] and prednisone [prednisone]. The patient had not started the medication yet due to a pharmacy order issue until (b)(6) 2022. On (b)(6) 2022, the hcp saw patient and she had signs of infection/biofilm (implant site infection) on the left cheek. She started the medications from the same day. On (b)(6) 2022, the patient reported that it was improving and the redness and tenderness were better. On (b)(6) 2022, the patient had called hcp and then came back in the office. She did not take doxycycline because it was looking better. The patient also reported that after the first follow up, she went home and had applied a powder/compact on her face which was like 6 months old. The hcp prescribed the doxycycline again. On (b)(6) 2022, the hcp spoke to patient and she said it was not improving. The patient also reported that this type of scenario had happened previously and her ent treated it with clindamycin. Therefore, the hcp changed the treatment to clindamycin [clindamycin]. On (b)(6) 2022, the hcp spoke to the patient and it was improving. On (b)(6) 2022, it was better as per the patient. On (b)(6) 2022, the patient came back to hcp office with signs of infection again. She was treated with 150 units of hyaluronidase [hyaluronidase] and moxifloxacin [moxifloxacin] for 21 days, a probiotic [probiotics nos] and continued with clindamycin. The patient also received treatment with clarithromycin [clarithromycin]. The patient had dermatology appointment on (b)(6) 2022. On (b)(6) 2022, the hcp spoke to the patient. On (b)(6) 2022, the patient stopped the medication and called back hcp. She said that area was swelling (implant site swelling) again. On (b)(6) 2022, the patient called hcp and said the swelling was gone. At this point hcp was not sure if she had developed a biofilm in the area. On (b)(6) 2022, the hcp reported that the patient had completed moxifloxacin and there were no signs of infection at the moment. However, the hcp would be seeing the patient in approximately 2 weeks. The hcp's primary concern was not knowing how to treat the patient if she continued with an infection despite all of the oral antibiotics prescribed to her. Outcome at the time of the report: red was recovered/resolved. Tenderness was recovered/resolved. Signs of infection/biofilm was recovered/resolved. Swelling was recovered/resolved. Restylane defyne was injected to piriform area was recovered/resolved.
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Manufacturer (Section D)
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
MDR Report Key13905360
MDR Text Key293367252
Report Number1000118068-2022-00007
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
Type of Report Initial,Followup
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number19488
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/07/2022
Distributor Facility Aware Date04/01/2022
Event Location Other
Date Report to Manufacturer04/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/25/2022 Patient Sequence Number: 1