Catalog Number 0400820000 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Discarded by customer.
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Event Description
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It was reported that during a surgical procedure at the user facility, the front material of the toga is separating from the inside material.The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.
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Manufacturer Narrative
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Upon further review, there was no allegation of a tear in the toga.A separation between the two layers in the toga material would not result in a breach in sterile barrier protection between the user and patient.Therefore, this event is not considered to be reportable per 21 cfr 803.3.
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Event Description
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It was reported that during a surgical procedure at the user facility, the front material of the toga is separating from the inside material.The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.
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Search Alerts/Recalls
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