Model Number UNK SURGIPRO MESH |
Device Problems
Material Erosion (1214); 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); Erosion (1750); Granuloma (1876); Unspecified Infection (1930); Injury (2348); Bowel Perforation (2668); No Code Available (3191)
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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 resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The per operative diagnosis was umbilical hernia and the post operative diagnosis was umbilical hernia, ventral hernia, placement of surgipro mesh graft and placement of on q pain pump.The patient experienced surgical revision, excision of granuloma caused by hernia mesh.
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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 umbilical and ventral hernia.It was reported that after implant, the patient experienced infection, granuloma, mesh erosion, adhesions, firm mass in umbilicus area, and small bowel perforation.Post-operative patient treatment included surgical revision, excision of mesh and excision of granuloma caused by hernia mesh.Relevant tests/laboratory data (b)(6) 2014: per op note, ct revealed firm mass in umbilicus area and ventral hernia superior to umbilicus with small bowel.
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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 umbilical and ventral hernia.It was reported that after implant, the patient experienced infection, granuloma, mesh erosion, and small bowel perforation.Post-operative patient treatment included surgical revision, excision of mesh and excision of granuloma caused by hernia mesh.
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Search Alerts/Recalls
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