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(b)(4).Date sent: 6/25/2024.B3: unknown; captured as awareness date.Investigation summary.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number 28740, and no non-conformances were identified.Additional information received: model: lxmc15.Device lot number: 28740.Date of surgery: (b)(6) 2022.Adverse event term: dysphagia.Sex: female.Age (at time of consent): 55 years.Severity : blank => moderate.Intervention/treatment: none: no.Relationship to study device : blank => probable.Relationship to study procedure : blank => not related.Outcome : unknown => recovering/resolving.Start date : blank => (b)(6) 2022.Observation: yes.Start date: (b)(6) 2023.Alert date: (b)(6) 2024.Country of event: us.Model: lxmc15.Device lot number: 28740.Date of surgery: (b)(6) 2022.Adverse event term: dysphagia.Patient details.Patient identifier: (b)(6).Sex: female.Age (at time of consent): 55 years.Additional event details.Site awareness date: 18 apr 2024.End date: blank.Severity: moderate.Is the adverse event serious? blank.Death: no.Date of death: blank.Life-threatening illness or injury: no.Permanent impairment of a body structure or a body function: no required in-patient hospitalization or prolongation of existing hospitalization: no admission date: blank discharge date: blank resulted in medical or surgical intervention: no led to fetal distress, fetal death or a congenital abnormality or birth defect: no relationship to study device: blank relationship to primary study procedure: blank if related to the procedure, indicate which procedure the event is related to: blank.Intervention/treatment: none: no.Dilation performed: no.Indicate type of dilation? blank.Date of dilation: blank.Diagnostic intervention: no.Diagnostic imaging: no.Drug therapy: no.Observation: no.Linx explant: no.Other surgical intervention: no.Other intervention/treatment: no.If other specify: blank.Outcome: blank.According to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated: blank did this event result in the patient¿s discontinuation of the study? blank.Updated log line 2: dilation performed : no => yes.Indicate type of dilation? : blank => mechanical.Intervention/treatment.(check 'none' or all that apply)none : yes => no.Updated log line 2: date of dilation : blank => (b)(6) 2023.Updated log line 2: if event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? : blank => n/a.Intervention/treatment.(check 'none' or all that apply)none : no => yes.Outcome : blank => recovering/resolving.Relationship to study device : blank => probable.Is the adverse event serious? (if yes, check all that apply) : blank => no.Relationship to study procedure : blank => not related.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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