The clinical complaint was adequately investigated.The lot number was verified and has been confirmed to be released by the company.It was observed that there has been a prior complaint (ref: (b)(4)) associated with lot# 20f030.The batch record, qc test reports, and training of staff were analyzed and it has been determined that product is within required specifications, and manufactured according to the appropriate procedures.
|
The clinic's medical director reported to the manufacturer that the patient, female was injected with 3 syringes of revanesse versa+ (with lidocaine); lot number 20f030 to correct an old past traumatic indentation in the left cheek, lips and naso labial folds.The patient return to the practice the next day with an allergic reaction to her face.He also reported without specifics that he has been treating her conservatively and has been seeing improvements.Medical director was consulted for his opinion and his clinical assessment is that it is more likely to be a reaction to a topical agent.The medical director's response was sent to the clinic on 14 oct 2020.The clinic medical director informed prollenium on 12 oct 2020 that he is waiting for a follow up with patient to respond to the information requested by prollenium on adverse event.No response was provided to date.Manufacturer will continue to communicate with the clinic.
|