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Model Number PNP8X3 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Swelling (2091); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Impaired Healing (2378)
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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 implant, the patient experienced post-op swelling, erythremia in skin overlying left groin, acute and chronic inflammation, infected mesh, severe pain and discomfort.Post-operative patient treatment included revision surgery.
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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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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 bilateral inguinal hernia.It was reported that after implant, the patient experienced post-op swelling, erythremia in skin overlying left groin, acute and chronic inflammation, infected mesh, severe pain, recurrence, open wound, draining, abscess, staph infection, purulent fluid, and discomfort.Post-operative patient treatment included revision surgery, explantation of mesh, and repair of hernia.
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Search Alerts/Recalls
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