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Model Number PCO9X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Nausea (1970); Pain (1994); Urinary Retention (2119); Hernia (2240); Discomfort (2330); Constipation (3274); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant device: ethicon securestrap, strap25, lot #: jc2852, tec1515 parietex std py 15x15cm x1, lot number: sod0015x.(b)(4).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 umbilical hernia and an inguinal hernia.It was reported that after implant, the patient experienced recurrence, abdominal pain, discomfort, tenderness, nausea, constipation, difficulty urinating, right groin mass, and groin pain.
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Search Alerts/Recalls
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