SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO3728 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Purulent Discharge (1812); Fever (1858); Pain (1994); Seroma (2069); Hernia (2240); Discomfort (2330); Ascites (2596); Abdominal Distention (2601); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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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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 implant, the patient experienced adhesions, recurrence, pain, seroma, mesh ingrowth, and yellow fluid.Post-operative patient treatment included revision surgery, mesh removal, mesh replacement, and excavation of yellow fluid.
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Manufacturer Narrative
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Additional info: d4 (expiration date), d10 (autosuture (x4) product id - abstack20, lot # - u8f48, lot # - n9b36), & h6 (patient codes, removed device code, ime e2402: induration, fluctuance).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 a laparoscopic therapeutic treatment of a i ncisional hernia.It was reported that after implant, the patient experienced adhesions, recurrence, pain, seroma, yellow fluid, fluid collection, hard induration, discomfort, tenderness, swelling, fluctuance, abdominal pain, bulge which interferes with daily acti vities, fever, & knot in lower abdomen.Post-operative patient treatment included revision surgery, mesh removal, hernia repair with mesh, excavation of yellow fluid, ct scan, drainage of seroma, medication, antibiotics, & abdominal binder.
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