SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2520OS |
Device Problems
Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Adhesion(s) (1695); Atrial Flutter (1730); Fistula (1862); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Ischemia (1942); Myocardial Infarction (1969); Nausea (1970); Necrosis (1971); Internal Organ Perforation (1987); Pain (1994); Seroma (2069); Vomiting (2144); Hernia (2240); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent an incisional herniorrhaphy with mesh.He had revision surgery 1 year and 8 months post surgery then again 2 years later and 3 months later and again 3 months post surgery.The patient experienced multiple surgical revisions, chronic pain, infection, and recurrence.
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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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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 incisional hernia.It was reported that after implant, the patient experienced chronic pain, infection, small bowel obstruction, fistula, seroma, small bowel perforation, adhesions, recurrence, abdominal free air and intra-abdominal fluid, inflammation, myocardial infarction, atrial flutter, abdominal distention, large hematomas, nausea, vomiting, hypotension, ischemic and necrotic bowel.Post-operative patient treatment included small bowel resection, lysis of adhesions, removal of mesh from wound, placement of ethicon vicryl mesh, pacemaker implanted, fluid resuscitation, recurrent ventral incisional hernia repair with bard ventralight st mesh, small-bowel resection with a 2 layer hand-sewn anastomosis, and evacuation of large subcutaneous hematoma and seroma.
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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 an incisional hernia.It was reported that after implant, the patient experienced chronic pain, infection, small bowel obstruction, fistula, seroma, small bowel perforation, adhesions and recurrence.Post-operative patient treatment included small bowel resection, lysis of adhesions, removal of mesh from wound, placement of ethicon vicryl mesh, recurrent ventral incisional hernia repair with bard ventralight st mesh.
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Search Alerts/Recalls
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