BAXTER HEALTHCARE CORPORATION PERI-GUARD; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
|
Back to Search Results |
|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Injury (2348)
|
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported from an anonymous survey result that the potential patient adverse reaction of the frequency of ¿foreign body reaction/ graft rejection/severe graft encapsulation¿ with use of peri-guard/supple peri-guard when used as a prosthesis for soft tissue deficiencies including defects of the thoracic wall in surgical procedures was rated moderate.The physician reported ¿i see this complication in approx 15% of my patients¿ (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.
|
|
Search Alerts/Recalls
|
|
|