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Model Number PCO1510X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Nausea (1970); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after the implant, the patient experienced recurrence.Post-operative patient treatment included small bowel resection and revision surgery.
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Manufacturer Narrative
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Additional information:a2, a3, a4, b2, b5, b7, h6(patient codes), additional codes.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after the implant, the patient experienced recurrence, pain, adhesions, obstruction, nausea, unable to lift more than 30lbs.Post-operative patient treatment included laparotomy with small bowel resection, mesh removal, medication, <(>&<)> revision surgery.
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Search Alerts/Recalls
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