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Model Number P101828 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
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Patient Problems
Adhesion(s) (1695); Hematoma (1884); Pain (1994); Hernia (2240); Impaired Healing (2378); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant devices: 10 x 14" mesh prolite ultra, lot # 30720, product id: 30720, 13 x 15cm graft bard allomax, lot # 175000000000535tissue#sj07k002, product id: 1180090, exp.Date 2013-03 10 x 15cm graft bard allomax, lot # 174000000000535tissue#sj07k002, product id: 1180080, exp.Date 2013-03.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 mesh detachment, mesh separation, hernia recurrence, mesh ruptured in middle creating hernia defect, mesh retracted laterally to both sides, neovascular attachments to the mesh, adhesions, open draining wound, hematoma, and chronic abdominal pain.Post-operative patient treatment included revision surgery, and remnants of mesh were removed.
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Search Alerts/Recalls
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