Model Number 404592 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Based on the available information, this event is deemed to be a reportable malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.
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Event Description
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Complaint reported by end user's daughter that the wafer was difficult to remove.No harm was reported.It was also reported that the end user had the same issues with a total of (3) boxes of the same product.No further information has been provided.
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Manufacturer Narrative
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A batch record review was acceptable and indicated no discrepancies related to this complaint.Process checks and quality checks were performed with acceptable results therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
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Search Alerts/Recalls
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