Catalog Number 130742203 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 04/16/2024 |
Event Type
Injury
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Event Description
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Subject id: (b)(6).Study no: (b)(6).Clinical adverse event received for infection.Event is serious and is considered moderate.Event is not related to device or procedure.Date of implant: (b)(6) 2024, date of event: (b)(6) 2024, (right shoulder).Treatment: injected medication.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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 depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product# 130742203/lot# 5624581 combination.Additionally sterilization records were review and no issues were found.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product# 130742203/lot# 5624581 combination.Additionally sterilization records were review and no issues were found.
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Search Alerts/Recalls
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