SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX COMPOSITE MESH MESH, SURGICAL, POLYMERIC
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Model Number PCO2520 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Fever (1858); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); Abdominal Distention (2601); 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 the implant, the patient experienced recurrence.
Post-operative patient treatment included revision surgery and hernia repair with new mesh.
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Search Alerts/Recalls
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