Catalog Number 0684-00-0434 |
Device Problems
Moisture Damage (1405); Device Damaged Prior to Use (2284); Device Packaging Compromised (2916)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/21/2017 |
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 21 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 13 of 21 of the devices.
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Manufacturer Narrative
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The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
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Event Description
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It was reported that 21 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 13 of 21 of the devices.
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Search Alerts/Recalls
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