SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX OPTIMIZED COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2520X |
Device Problems
Mechanical Problem (1384); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Emotional Changes (1831); Erythema (1840); Fistula (1862); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Scarring (2061); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559)
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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 a procedure where this device was implanted, the patient experienced surgical revision and excision.After treatment, the patient experienced removal.
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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 a hernia.It was reported that after a procedure where this device was implanted, the patient experienced surgical revision, excision.After treatment, the patient experienced removal.
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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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced extensive abdominal scarring, abdominal fluid collections, multiple draining fistulous tracts, and infection.Post-operative patient treatment included surgical revision, mesh removal, open debridement of anterior abdominal wall skin, muscle, fat, fascia, and wound vac.
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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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced extensive abdominal scarring, abdominal fluid collections, multiple draining fistulous tracts, chronic abdominal wound, abscess, mental pain, physical pain, suffering, disability, impairment, loss of enjoyment of life, loss of care/comfort/consortium, defective device, failure of mesh, and infection.Post-operative patient treatment included surgical revision, mesh removal, open debridement of anterior abdominal wall skin, muscle, fat, fascia, and wound vac.
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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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Search Alerts/Recalls
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