The reported product is an unknown baxter peri-strips psd-v with gel.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.
|
It was reported from an anonymous survey result that the percentage of patients that had reoperations due to staple line leaks or staple line bleeding after using peri-strips with gel for the reinforcement of staple lines during bariatric surgical procedures was 1-3%.The physician reported ¿had issue with redo and take back due to staple line failure" (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.
|