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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Based on the information provided, the patient got injected with revanesse dermal fillers in the unspecified area of the patient on (b)(6) 2022.The lot of the product injected was not provided and, therefore, not verified.Amount of product injected was not specified.Date of birth not provided.According to the initial communication, after about two weeks the patient was having unusual pain when sleeping on his side.After about three weeks, the patient had an intense burning anytime the patient tried to wash or use any products.Patient has been to several doctors.Patient has been back to the injector as well as a dermatologist.Patient did not wish to go back to the injector.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.Since the day of notification, the qa department has attempted to investigate the clinic and injector information.Patient was called via the phone number provided in the initial report, however no response has been received.As of 25 mar 2022, no response from the patient has been received.The qa department at prollenium medical technologies will continue the investigation.
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