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Model Number PCO6VP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Necrosis (1971); Pain (1994); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant product: ethicon securestrap strap25, lot #: mm6424, product id: lab100174763v1, exp: 10/2020.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 abdominal hernia.It was reported that after implant, the patient experienced small bowel obstruction, adhesions, abscess, pain, and necrotic-appearing tissue.Post-operative patient treatment included revision surgery.
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Search Alerts/Recalls
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