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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Type
Injury
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Manufacturer Narrative
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Date of event: (b)(6) 2009 to (b)(6) 2014.Chang, craig g.,thackeray, lisa.¿laparoscopic hiatal hernia repair in 221 patients: outcomes and experience¿.Journal of the society of laparoendoscopic surgeons, (january¿march 2016): volume 20 issue 1 e2015.00104.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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A patient underwent a laparoscopic hiatal hernia repair to reduce and/or alleviate gastroesophageal reflux disease (gerd) symptoms and associated hiatal recurrence in which veritas was used as a biologic mesh re-enforcement.Veritas was placed over the cruroplasty, which was previously sutured using braided polyester sutures, and was used to strengthen the repair.This was then sutured to the diaphragm at multiple points using interrupted 0 vicryl sutures.The surgery was performed using an onlay technique (of the biological mesh).Post operatively, the patient developed an unspecified wound infection.The cause of the event was not specified.No further information was provided regarding if the patient was hospitalized for the event or if any medical interventions were needed.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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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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Search Alerts/Recalls
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