COOK INC COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS; KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
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Catalog Number J-SOSR-100500 |
Device Problem
Hole In Material (1293)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
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Event Description
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It was reported that during pretesting of the device, the balloon failed, a hole was noted in the balloon material.
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Search Alerts/Recalls
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