Model Number SIZE 1 |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history record (dhr) and supporting quality records confirmed no anomalies that may have caused or contributed to the malfunction.
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Event Description
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Consumer reported the string was not attached to the pessary.She did not use the affected pessary.
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Manufacturer Narrative
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New information: b5: three companion samples were returned by the consumer.The string on one bladder support was in two pieces, but still attached to the bladder support.No product defects or abnormalities were observed with the other two bladder supports.
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Event Description
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Three companion samples were returned by the consumer.The string on one bladder support was in two pieces, but still attached to the bladder support.No product defects or abnormalities were observed with the other two bladder supports.
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Search Alerts/Recalls
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