Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Swelling/ Edema (4577); Insufficient Information (4580)
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Event Date 03/24/2022 |
Event Type
Injury
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Event Description
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Based on the information provided, the patient got injected with revanesse dermal fillers in the unspecified area of the patient.The lot of the product injected was not provided and, therefore, not verified.Amount of product injected was not specified.Date of birth and gender of the patient are not provided.According to the initial communication, the patient experienced swelling and tightness.No information regarding topic anaesthetic has been provided.No information regarding allergies has been provided.No information regarding medical history and presence of risk factors have been provided.On the day of notification, the qa department reached out to the clinic and injector.As of (b)(6) 2022, no further information regarding the event has been received.The qa department at prollenium medical technologies will continue the investigation.
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Manufacturer Narrative
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The clinical complaint is in the process of investigation.The lot number has not been verified due to the absence of information.It will be confirmed whether any clinical complaints have been found for the particular lot number in question once requested information is provided.The batch record, qc test reports, and training of staff will be analysed and be determined that product is within required specifications, and manufactured according to appropriate procedures once lot is verified.Prollenium medical technologies' medical director's response to this adverse event will be provided to the clinic along with the letter indicating approved areas for injection for revanesse versa+ and revanesse lips+ products when requested information for conducting investigation is provided.
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Event Description
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Treatment information: based on the information provided, the patient got injected with revanesse dermal fillers in the unspecified area of the patient.The lot of the product injected was not provided and, therefore, not verified.Adverse event information: unspecified.Results of internal investigation:owing to the lack of information provided (no product variant information, no lot number information) the manufacturer cannot complete its internal investigations.Results of medical assessment: prollenium medical technologies inc.Medical director opinion could not be consulted as adequate information was not provided during follow ups with clinics to make a suitable medical assessment.Prollenium will be concluding its investigations and closing this report.Internal report number: (b)(4).
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Search Alerts/Recalls
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