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
Injury (2348)
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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 patch rupture/tear with use of peri-guard when used as a prosthesis for intra-cardiac and great vessel repair was rated moderate.The physician reported ¿post-op¿ (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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Manufacturer Narrative
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Additional information, b5: upon follow up it was reported that there was no rupture or tear; therefore, the peri-guard product is no longer considered suspect product in this event.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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