Model Number MXPCONDS02 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 03/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).
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Event Description
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Complainant ordered another pessary, which was even larger than the first replacement, though it was also marked 70mm.It also made the patient bleed.
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Manufacturer Narrative
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It has been approximately 50 days and the reported sample has not been returned for investigative analysis.This product is molded and packaged at coopersurgical.A review of two year complaint history shows no complaints.The reported complaint did not furnish a lot number.A sampling of current finished goods inventory did not find any mixed product.It should be noted that as part of the bagging process: prior to placing in the bag, each piece is 100% inspected for size by a vision system.There have not been any recent changes to process or specifications.The reported complaint could not be confirmed.
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Event Description
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Complainant ordered another pessary, which was even larger than the first replacement, though it was also marked 70mm.It also made the patient bleed.1216677-2019-00135-1 incont dish w-sp-65mm-2 mxpconds02 (b)(4).
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Search Alerts/Recalls
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