Model Number NOT APPLICABLE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Granuloma (1876)
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Event Type
Injury
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Event Description
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According to the received information, the patient was injected with an unknown amount of teosyal rha 3 in the lips in (b)(6) 2021.On an unknown date, the patient noticed a granuloma on the lip.On (b)(6) 2022, symptoms were still ongoing and it was unknown if a treatment had been given to the patient.Despite reminders, no additional information could be retrieved at the time of this report.
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Manufacturer Narrative
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Additional mfr narrative: granulomas are known and widely documented effects in the context of hyaluronic acid filler injections.They are caused by a delayed immune reaction of the body in response to the implant being treated as a foreign body.As it is unable to eliminate the implant, the body surrounds it with immune cells (macrophages) forming a more or less hard and inflammatory mass.Appropriate medical treatment generally allows to treat these reactions quickly and effectively the risk of such reaction is mentioned in the instructions for use of teosyal products.
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Event Description
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According to the received information, the patient was injected with an unknown amount of rha 3 in the lips in december 2021.On an unknown date, the patient noticed a granuloma on the lip.On 10 march 2022, symptoms were still ongoing and it was unknown if a treatment had been given to the patient.Despite reminders, no additional information could be retrieved at the time of this report therefore complaint was closed as is.
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Event Description
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According to the received information, the patient was injected with an unknown amount of rha 3 in the lips in (b)(6) 2021.On an unknown date, the patient noticed a granuloma on the lip.On (b)(6) 2022, symptoms were still ongoing and it was unknown if a treatment had been given to the patient.Despite reminders, no additional information could be retrieved at the time of this report therefore complaint was closed as is.
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Manufacturer Narrative
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Additional mfr narrative: granulomas are known and widely documented effects in the context of hyaluronic acid filler injections.They are caused by a delayed immune reaction of the body in response to the implant being treated as a foreign body.As it is unable to eliminate the implant, the body surrounds it with immune cells (macrophages) forming a more or less hard and inflammatory mass.Appropriate medical treatment generally allows to treat these reactions quickly and effectively the risk of such reaction is mentioned in the instructions for use of teosyal products.
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Search Alerts/Recalls
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