Catalog Number 0684-00-0434 |
Device Problems
Moisture Damage (1405); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.We continue our efforts to follow up for its return.(b)(4).
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Event Description
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It was reported that 18 devices of this batch have fluid visible between the tray and tray cover with no sign of fluid contamination from the outside.The packaging is reported to be intact.This was reported by a distributor in (b)(6).This product was not shipped to the end user and therefore there was no patient involvement.This mdr is for 4 of 18 of the devices.
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Manufacturer Narrative
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Despite our good faith efforts, the product was not returned and so could not be evaluated.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The complaint could not be confirmed.Complaint # (b)(4); record id: (b)(4).
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Event Description
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It was reported that 18 devices of this batch have fluid visible between the tray and tray cover with no sign of fluid contamination from the outside.The packaging is reported to be intact.This was reported by a distributor in (b)(6).This product was not shipped to the end user and therefore there was no patient involvement.This mdr is for 4 of 18 of the devices.
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Search Alerts/Recalls
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