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Model Number VTX3030M |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant device: biosurgery (product id: f10256-1620g, lot number: ert-6h14) and bard sorbafix (product id: 0113116, lot number: hubx1139).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 an abdominal hernia.It was reported that after implant, the patient experienced recurrence, adhesions to small intestine, and scarring.Post-operative patient treatment included revision surgery and mesh removal.
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Search Alerts/Recalls
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