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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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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 was 1-3%.The physician reported ¿even if the patient is doing well clinically, it is safest to observe in the hospital¿ (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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Manufacturer Narrative
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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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Search Alerts/Recalls
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