SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX COMPOSITE MESH MESH, SURGICAL, POLYMERIC
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Model Number PCO15 |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Purulent Discharge (1812); Emotional Changes (1831); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Discomfort (2330); Injury (2348); No Code Available (3191); 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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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, infection 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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Search Alerts/Recalls
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