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 Problem
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 with use of peri-guard when used as a prosthesis for pericardial closure was rated moderate for frequency of severe or prolonged inflammation.The physician reported ¿have seen severe inflammatory response when using brand in other locations¿ (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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