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Catalog Number EMW810T |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Inflammation (1932)
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Event Date 03/12/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).A manufacturing record evaluation was performed for the finished device lot number am5937, code: emw810t, and no non-conformances / manufacturing irregularities were identified.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.The patient demographic info: age, gender, weight, bmi at the time of index procedure date and name of the index surgical procedure.Where in the patient¿s body was the device placed? patient symptoms- describe the manifestation of reaction (location, severity, appearance, systemic or local reaction) what was the onset date from the time of the index surgery? please describe the ¿relevant allergy treatment¿ that was given, i.E., medication name, dose, route (oral, iv, topical, etc), amount of time administered.Other relevant patient history/concomitant medications product code? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.
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Event Description
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It was reported that the patient underwent an unknown surgery on an unknown date and bone wax was used.Following the procedure, the patient experienced inflammation and allergy.The patient received relevant allergy treatment.Additional information has been requested.
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Manufacturer Narrative
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Date sent to the fda: 07/24/2020.Additional information was requested, and the following was obtained: reply to the follow-up: unknown, due to after follow-up attempt, no information can be provided from the hospital.The patient demographic info: age, gender, weight, bmi at the time of index procedure date and name of the index surgical procedure.Where in the patient¿s body was the device placed? was the excess bone wax removed from the operative site? patient symptoms- describe the manifestation of reaction (location, severity, appearance, systemic or local reaction).What was the onset date from the time of the index surgery? please describe the ¿relevant allergy treatment¿ that was given, i.E., medication name, dose, route (oral, iv, topical, etc), amount of time administered.Other relevant patient history/concomitant medications product code? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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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Search Alerts/Recalls
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