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 percentage of patients that were readmitted due to staple line leaks or staple line bleeding after using peri-strips with gel for the reinforcement of staple lines during gastric, inclusive of small bowel procedures was 1-3%.The physician reported ¿1-3% leak rate includes the referral/transfers from other hospitals or correction of other services complications my leak rate is less than 1%¿ (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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