The clinical complaint has been adequately investigated.The lot number has been verified and has been confirmed to be released by the company.It has been confirmed that there was one previous clinical complaint ((b)(4)) have been found for the particular lot number in question.The batch record, qc test reports, and training of staff were analysed and it has been determined that product is within required specifications, and manufactured according to appropriate procedures.Prollenium medical technologies' medical director's response to this adverse event will be provided to the clinic: "the following is a clinical opinion based on the limited information provided below; on (b)(4) the patients had her lips injected with lips+ ha, by a physician.There were no other treatments documented nor was there any injections or treatments in the peri-orbital area.On july 21 the patient reported a bruise in the left under eye area, specifically in the tear trough region.The one photo provided shows a small bruises with no swelling or other clinical findings.The photo does not show the lip area where the injection occurred.The history and photo do not show an adverse event related to the injection.It is assumed that the injecting doctor ruled out any remote vascular events.The photo and limited history show no evidence of this.The tissue around the eye is very thin and well vascularized, so it is very easily bruised by everyday events like rubbing or scratching the area.Even an episode of coughing or straining can cause a tiny vessel to leak and create a bruise.My clinical opinion is that the small bruise on the patients lower lid is coincidental and not related to her prior lip injection.I see no evidence that this is an adverse event related to ha injection.I trust this opinion is of value to all parties concerned." at the moment of this report, it was decided to put the account of clinic on hold and prohibit future orders from prollenium medical technologies until two active adverse events are resolved.
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Based on the information provided from the clinic, on (b)(6) 2021 - date of treatment with revanesse lips+ injected in the lips area of the patient.On wednesday, (b)(6) 2021 - patient has reached out to clinic and has informed that she had a black eye.The clinic and representative were reached out multiple amount of times.On (b)(6) 2021, shortly after reporting adverse event, qa department has reached out clinic requesting required information regarding event.Clinic was also reached via telephone requesting information about this ae.Clinic has informed that they will provide more information shortly.On (b)(6) 2021, qa department tried to follow up with the clinic regarding this ae, however, no response have been received.On (b)(6) 2021, qa department tried to follow up again via email however, no response have been received.On (b)(6) 20211, qa department has emailed sales representative regarding the follow-up and to inquire information directly from clinic.On (b)(6) 2021, qa department tried to follow up again via email however, no response have been received.No reply has been received as of (b)(6) 2021.Qa department will continue investigation.Photos of patient and email communication with medical director are attached to this report.Note: provided description of event were partially reported based on the phone call with injector and qa associate.
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