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.
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It was reported from an anonymous survey result that the potential patient response risk with the use of peri-strips with gel for the reinforcement of staple lines during bariatric surgical procedures was rated high for risk buttress leak at staple line-gastric leak.The physician reported " safety" (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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