ZIMMER SURGICAL, INC. 400 ML COMP EVAC 1/8" PVC W/TROCAR 3,2MM 10FR PVC; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
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Catalog Number 00250000010 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 08/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).The device history record (dhr) for the 400 ml comp evac 1/8" pvc w/trocar 32 mm, 10 fr pvc, part number 00250000010, review could not be performed as a lot number was not provided for the reported event.A returned product investigation could not be performed for the reported event due to the product not being returned for evaluation.The reported event can, therefore, not be confirmed.The root cause of the reported event cannot be specifically determined with the provided information because the product was not returned for evaluation.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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Event Description
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It was reported that the patient underwent a procedure on (b)(6) 2019.The patient came back for the first month follow up and it was discovered they retained foreign body.This was removed on (b)(6) 2019.This was discarded.No additional patient consequences were reported.
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