Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Obstruction/Occlusion (2422); Insufficient Information (4580)
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Event Date 01/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).Follow-up emdr for device evaluation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that intraperitoneal adhesion formation, loculation formation within the peritoneal cavity, and occlusion.Intraperitoneal adhesion formation ¿ 6.Loculation formation within the peritoneal cavity ¿ 6.Occlusion - 1.
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Manufacturer Narrative
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(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).Follow-up emdr for device evaluation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that intraperitoneal adhesion formation, loculation formation within the peritoneal cavity, and occlusion.Intraperitoneal adhesion formation ¿ 6.Loculation formation within the peritoneal cavity ¿ 6.Occlusion - 1.
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Search Alerts/Recalls
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