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Model Number GBF0508 (SUSPECTED) |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling (2091); Patient Problem/Medical Problem (2688)
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Event Date 12/31/2015 |
Event Type
Injury
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Manufacturer Narrative
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On 06/05/2018, suneva complaint department received medwatch mw5077411.Patient indicates "serious injury" under event report type, indicating reoccurring pain and swelling, as well as "growth" of the implant.Patient also indicates that a facelift will be required to resolve the issue.More details can be found on mw5077411.No other information was provided after multiple attempts to reach the patient with the phone number and email address noted on the medwatch form.Lot number and injector are unknown.Location of injections and/or bellafill use cannot be confirmed.Suneva could not find this same complaint in their complaint history and so are providing this mdr based on the patient statement in mw5077411 and selection of "serious injury" under event report type.Additional info regarding in this emdr report: similar terms to "growth" of the implant could not be found.(b)(4).
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Event Description
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Patient, via medwatch mw5077411, indicates "serious injury," relaying reoccurring pain and swelling, as well as growth of the implant.Patient also implies that a facelift will be required to resolve.
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Search Alerts/Recalls
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