(b)(4).Date of event: unknown.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What were the indications for surgery? what is the product code for the fenix? what is the lot number for the fenix? what was the implant date? what was the explant date? when was the infection diagnosed? please provide patient demographics (age, gender, co-morbidities, ect).Did the device erode prior to the infection? how is the patient now?.
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(b)(4).Date sent: 08/26/2019.The lot was not provided; therefore, the manufacturing records could not be reviewed.Additional information was requested, and the following was obtained: what were the indications for surgery? the patient had a persistent low-grade wound infection.What is the product code for the fenix? fs** (unsure of device size).What is the lot number for the fenix? not available.What was the implant date? (b)(6) 2016.What was the explant date? (b)(6) 2019.When was the infection diagnosed? low-grade infection noted at 6 month post implant, patient having good results, did not want device removed.Please provide patient demographics (age, gender, co-morbidities, ect).Female, unsure of other details.Did the device erode prior to the infection? no.How is the patient now? doing fine per surgeon.The fenix device was not retained by the hospital and will not be returned.
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