The reported product is an unknown baxter peri-strips 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 percentage of patients that experienced staple line leaks or staple line bleeding following surgery with use peri-strips with gel for the reinforcement of staple lines during bariatric surgical procedures was 1-3%.The physician reported ¿only has been minimal cases and easy fixable during procedure¿ (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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