MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 4; DERMAL FILLER

Model Number	NOT APPLICABLE
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	02/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further attempts will be made to obtain the batch number.
Event or Problem Description
According to the information received on 14-feb-2022, a patient was injected on 11-feb-2022 with a rha 4 product to each cheek.During the injection, the patient felt intermittent headache pain, which lasted for a few days.As corrective treatment she was recommended to take tylenol.Instantly after the injection, the patient experienced considerable bruising and was prescribed arnica gel.In addition, that same afternoon, the patient experienced blurred vision in both eyes, which lasted all day and improved in the next morning.The patient also reported some weakness all over the body, tingling in the arms, as well as tiredness.The patient was concerned that this might be a stroke but the diagnosis was not confirmed by a healthcare professional.The patient was recovering from the bruising, the weakness and the tingling and recovered from the blurred vision.
Event or Problem Description
According to the information received on 14-feb-2022, a patient was injected on (b)(6) 2022 with a rha 4 product to each cheek.During the injection, the patient felt intermittent headache pain, which lasted for a few days.As corrective treatment she was recommended to take tylenol.Instantly after the injection, the patient experienced considerable bruising and was prescribed arnica gel.In addition, that same afternoon, the patient experienced blurred vision in both eyes, which lasted all day and improved in the next morning.The patient also reported some weakness all over the body, tingling in the arms, as well as tiredness.The patient was concerned that this might be a stroke but the diagnosis was not confirmed by a healthcare professional.The patient was recovering from the bruising, the weakness and the tinglings and recovered from the blurred vision.Final : following internal discussions with a us medical expert, this case was downgraded to non-serious.Indeed, the event of stroke is the patient's subjective assumption and was not confirmed by any hcp.
Additional Manufacturer Narrative
Additional mfr narrative: despite several attempts the batch number could not be obtained.

• Brand Name: TEOSYAL RHA 4
• Common Device Name: DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon; 105; geneva 1203 ; CH 1203
• Manufacturer (Section G): TEOXANE SA; rue de lyon; 105; geneva 1203 ; CH 1203
• Manufacturer Contact: nicolas caill ; rue de lyon; 105; geneva 1203 ; CH 1203 ; 022344-9636
• MDR Report Key: 13794558
• Report Number: 3005975625-2022-00079
• Device Sequence Number: 11717994
• Product Code: LMH
• UDI-Device Identifier: 07640173230069
• UDI-Public: 07640173230069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: QUERIED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female