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Model Number PCO3020OSX |
Device Problems
Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Staphylococcus Aureus (2058); Sepsis (2067); Discharge (2225); Hernia (2240); Injury (2348); Ascites (2596); 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 a hernia repair with mesh.The patient underwent a revision surgery.The patient had infected abdominal mesh, dense adhesions to the recuts musculature as well as omentum and stomach beneath.The mesh had become rolled up on itself.The mesh was excised.
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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 devic.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced infected abdominal mesh, recurrence, antero-mesh fluid collection, hospitalization for sepsis, mesh rolled onto itself, spontaneous drainage and pain from abdominal wound, dense adhesions to the recuts musculature as well as omentum and stomach beneath and foreign body.Post-operative patient treatment included mesh excision, closure of abdominal wound, operative exploration with selective debridement, re-exploration of abdominal wound, removal of foreign body, repair of incisional hernia, evacuation of fluid collection and wound vac.
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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 of an incisional hernia.It was reported that after implant, the patient experienced infected abdominal mesh, antero-mesh fluid collection, spontaneous drainage and pain from abdominal wound complicated abdominal wound, dense adhesions to the recuts musculature as well as omentum and stomach beneath.The mesh had become rolled up on itself.Post-operative patient treatment included mesh excision, closure of abdominal wound, operative exploration with selective debridement, re-exploration of abdominal wound, debridement, and evacuation of fluid collection and wound vac relevant tests/laboratory data, including dates: (b)(6) 2015: op note- wound cultures positive for (b)(6).
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Search Alerts/Recalls
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