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 gastric, inclusive of small bowel surgical procedures was rated high for the risk of infection.The physician reported ¿patients had infection after its use¿ (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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