Catalog Number 0600021 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Inflammation (1932)
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Event Date 05/19/2023 |
Event Type
Injury
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Event Description
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A tetralogy of fallot patient underwent a blalock-taussig shunting surgery in which coseal spray set was used.It was reported seven days post-operative the patient experienced mediastinitis.The patient was treated with vancomycin.At the time of this report, the patient outcome was not reported.No additional information is available.
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Manufacturer Narrative
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A2: date of birth: (b)(6) 2022 a4: weight: 4659 grams.G1: device manufacturer postal code:
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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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