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Model Number SPM-35 |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Ecchymosis (1818); Emotional Changes (1831); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Scarring (2061); Swelling (2091); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 was reported that after a procedure where this device was implanted, the patient experienced surgical revision, infection.After treatment, the patient experienced revision surgery.
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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 an epigastric hernia.It was reported that after implant, the patient experienced mental pain, pain/suffering, device defective, mesh failure, disability, impairment, loss of enjoyment of life, hematoma, exposed mesh, infection, inflammation, hernia recurrence, abscess, open wound, sinus drainage, staph aureus, ecchymosis, swelling, purulent material, granulation tissue, induration, scarring, sinus tract, and abdominal pain.Post-operative patient treatment included revision surgery, removal of graft material, incision and drainage of infection, old hematoma debrided, wound packed, antibiotics, and herniorrhaphy.
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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 epigastric hernia.It was reported that after implant, the patient experienced infection, abscess, open wound, sinus drainage, staph aureus, ecchymosis, swelling, inflammation, purulent material, hematoma, granulation tissue, pain, induration, scarring, sinus tract, and recurrence.Post-operative patient treatment included revision surgery, removal of graft material, incision and drainage of infection, old hematoma debrided, wound packed, antibiotics, and herniorrhaphy.
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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 epigastric hernia.It was reported that after implant, the patient experienced infection, abscess, open wound, and recurrence.Post-operative patient treatment included revision surgery, removal of graft material, and herniorrhaphy.
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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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Search Alerts/Recalls
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