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Model Number SPM-35 |
Device Problems
Material Perforation (2205); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Wound Dehiscence (1154); Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Gangrene (1873); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Perforation (2001); Tachycardia (2095); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); 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.
It was reported that after implant, the patient experienced adhesions, infection and recurrence.
Post-operative patient treatment included 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 incarcerated left inguinal hernia.
It was reported that after implant, the patient experienced adhesions, infection, recurrence, strangulated left inguinal hernia containing perforated and gangrenous sigmoid colon, tachycardia, wound dehiscence, prolapsing colostomy, purulent drainage from left inguinal incision, open wound and chronic drainage of the left inguinal wound.
Post-operative patient treatment included revision surgery, mesh removal, exploratory laparotomy, partial colectomy, colostomy, wound vac placement due to pneumoperitoneum, takedown of colostomy, lysis of adhesions, left inguinal wound exploration due to left inguinal hernia, parastomal hernia and left inguinal hernia wound.
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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 incarcerated left inguinal hernia.
It was reported that after implant, the patient experienced adhesions, infection, recurrence, strangulated left inguinal hernia containing perforated and gangrenous sigmoid colon, tachycardia, wound dehiscence, prolapsing colostomy, purulent drainage from left inguinal incision, and chronic drainage of the left inguinal wound.
Post-operative patient treatment included revision surgery.
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Search Alerts/Recalls
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