Model Number GBF0508 (SUSPECTED) |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Manufacturer Narrative
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Patient reported "permanent marks" after off-label injection under the eyes.Patient states that her injector is aware of the issue and tried to "fix it" but it did not do anything.She is not going back to the injector who she would not name.She also relayed that she had a 2nd opinion by a plastic surgeon (who she would not name) who said to wait and that it would probably fade away over a period of years.He also relayed to the patient that it was inoperable and would look worse after surgery.Patient would not provide additional information stating she didn't see the point in reporting.Lot number and injector are unknown.Bellafill use cannot be confirmed.Bellafill is indicated for correction of the nasolabial folds and acne scars in the cheeks.
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Event Description
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Patient reported "permanent marks" under the eyes after off-label bellafill injection.
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Manufacturer Narrative
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Patient reported "permanent marks" after off-label injection under the eyes.Patient states that her injector is aware of the issue and tried to "fix it" but it did not do anything.She is not going back to the injector who she would not name.She also relayed that she had a 2nd opinion by a plastic surgeon (who she would not name) who said to wait and that it would probably fade away over a period of years.He also relayed to the patient that it was inoperable and would look worse after surgery.Patient would not provide additional information stating she didn't see the point in reporting.Lot number and injector are unknown.Bellafill use cannot be confirmed.Bellafill is indicated for correction of the nasolabial folds and acne scars in the cheeks.Follow-up #1: corrected information.The suspected model/catalog # is gbf0508.
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Event Description
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Patient reported "permanent marks" under the eyes after off-label bellafill injection.
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Search Alerts/Recalls
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