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
Foreign Body Reaction (1868); Inflammation (1932)
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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 foreign body reaction/ graft rejection/severe graft encapsulation with use of peri-guard/supple peri-guard when used as a prosthesis for pericardial closure was rated moderate.The physician reported ¿¿in the case of pericarditis with inflammation, like after a transmural mi¿ (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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