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Lot Number 17327
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Discoloration (2074); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/04/2022
Event Type  Injury  
Manufacturer Narrative
Company comment: the serious event of vascular occlusion and the non-serious events of discolouration at implant site and poor peripheral circulation were considered expected and possibly related to the treatment. Serious criteria include the need for medical intervention to prevent permanent damage. The likely root cause include intravascular filler injection leading to vascular occlusion and its manifestations. Potential contributory factor include patient's previous surgical rhinoplasty and filler treatment in the affected area. The restylane-l was used off label. The case meets the criteria for expedited reporting to the regulatory authorities. Evaluation text: restylane lidocaine-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: 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 (b)(6) 2022 by a physician concerning a (b)(6) male patient. Additional information was received from the same reporter via other hcp on 18-apr-2022. The patient's medical history included surgical rhinoplasty. The patient had no known allergies. No information about concomitant medications has been provided. The patient had previously received treatment with rha2 to nasal area on (b)(6) 2021. On an unknown date, the patient had received an unspecified covid-19 vaccine. The patient not had any illness in the month prior to the treatment. On (b)(6) 2022, the patient received treatment with 0. 9 ml restylane-l (lot 17327) to nasal radix, tip using supplied needle with unknown injection technique for facial rejuvenation. The restylane-l was injected to nasal radix, tip (off label use of device). Same day, the patient had experienced a possible vascular occlusion (vascular occlusion) in the nose. The patient was treated with 500 mg hylenex [vorhyaluronidase alfa]. Following hylenex treatment, there was an improved color (implant site discolouration) and improved blood flow/capillary refill (poor peripheral circulation). On (b)(6) 2022, the patient was treated with additional 450 mg of hylenex. There was an improvement in color and blood flow/capillary refill. On (b)(6) 2022, the patient was treated again with 450 mg of hylenex and then the color was normalized and capillary refill was good. On (b)(6) 2022, the vascular occlusion was resolved. Outcome at the time of the report: possible vascular occlusion was recovered/resolved. Improved color was recovered/resolved. Improved blood flow/capillary refill was recovered/resolved. Restylane-l was injected to nasal radix, tip was recovered/resolved.
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Manufacturer (Section D)
seminariegatan 21
uppsala, SE-75 228
SW SE-75228
MDR Report Key14193075
MDR Text Key289966955
Report Number1000118068-2022-00010
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
Report Date 04/25/2022,04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2022
Device Lot Number17327
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/25/2022
Distributor Facility Aware Date04/05/2022
Event Location Outpatient Treatment Facility
Date Report to Manufacturer04/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/25/2022 Patient Sequence Number: 1