Model Number UNKNOWN PROGRIP |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Cyst(s) (1800); Purulent Discharge (1812); Internal Organ Perforation (1987); Pain (1994); Swelling (2091); Hernia (2240); Injury (2348); 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 patient underwent the repair of right inguinal hernia repair with mesh, anterior approach.The patient experienced surgical revision, pain, organ perforation and recurrence.
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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 right inguinal hernia repair with mesh, anterior approach.It was reported that after the implant, the patient experienced organ perforation, recurrence, swelling, purulent drainage, cysts, and redness.Post-operative patient treatment included revision surgery, groin exploration with washout of wound infection, removal of mesh, and wound vac.
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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 right inguinal hernia repair with mesh, anterior approach.The patient experienced pain, organ perforation and recurrence.Post-operative patient treatment included revision surgery.
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Search Alerts/Recalls
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