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Model Number P101010 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Erosion (1750); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Fluid Discharge (2686); No Code Available (3191)
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Event Type
Injury
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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 parastomal hernia.
It was reported that after implant, the patient experienced pain, adhesions, abscess, bowel obstruction, erosion, infection, seroma and recurrence.
Post-operative patient treatment included revision surgery, aspiration of seroma, lysis of adhesions and recurrence repair.
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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.
Pre-operative and post-operative diagnosis: incarcerated obstructing parastomal hernia.
Procedure: reduction of the hernia via parastomal approach with mesh repair of the defect.
Events: the patient had surgical revisions, paid, adhesions, bowl obstruction, erosion, infections, seroma, and recurrence.
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Search Alerts/Recalls
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