SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ OPTIMIZED COMPOSITE MESH MESH, SURGICAL, POLYMERIC
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Model Number PCO12X |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
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Patient Problems
Unspecified Infection (1930); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Swelling (2091); Hernia (2240); Injury (2348); Ambulation Difficulties (2544); Abdominal Distention (2601); No Code Available (3191)
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Event Type
Death
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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 ventral hernia.
It was reported that after a procedure where this device was implanted, the patient experienced recurrent incisional hernia, stomach pain, swelling, intestinal protrusion, difficulty walking, continuous digestive problems, perforation of tissue/organs, adherence to tissue/organs, infection, nerve damage, subsequent surgeries and other complications.
Treatment and potentially related procedures include additional surgery.
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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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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 ventral hernia.
It was reported that after a procedure where this device was implanted, the patient experienced recurrent incisional hernia, stomach pain, swelling, intestinal protrusion, difficulty walking, continuous digestive problems, perforation of tissue and/or organs, adherence to tissue/organs, infection, and nerve damage.
Treatment for these issues included subsequent surgeries.
Information received indicates the patient is deceased.
No information was provided regarding the circumstances of expiration or any association with this device.
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Search Alerts/Recalls
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