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); 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 the frequencies of foreign body reaction/ graft rejection/severe graft encapsulation, seroma and severe immune response with use of peri-guard when used as a prosthesis for intra-cardiac and great vessel repair was rated moderate.The physician reported ¿occasionally but well treatable¿ (foreign body reaction), ¿rare problem¿ (seroma) and ¿occasionally observed¿ (immune response).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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