BAXTER HEALTHCARE CORPORATION PERI-GUARD; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Seroma (2069)
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Event Type
Injury
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Manufacturer Narrative
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The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported from an anonymous survey result that the potential patient adverse reaction for frequency of severe or prolonged inflammation, stricture, seroma and delamination with use of peri-guard when used as a prosthesis for intra-cardiac and great vessel repair were rated moderate.The physician reported ¿treatment of suspected inflammatory local occurrences associated with foreign bodies¿, ¿a rare event occurred nevertheless¿ (stricture), ¿conservative treatment, if necessary puncture / discharge¿ (seroma) and ¿delamination could damage the elastic stability¿ (no further details).At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.
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Search Alerts/Recalls
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