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Model Number UNK SURGIPRO MESH |
Device Problems
Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Hernia (2240); Injury (2348); 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.The product was used for therapeutic treatment of hernia.It was reported that after implant, the patient experienced adhesions and hernia recurrence.Post-operative patient treatment included revision and removal 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 recurrent ventral incisional hernia.It was reported that after implant, the patient experienced adhesions, recurrence, epigastric pain, difficulty eating, diverticulitis, uti, dyspepsia, gerd, propylene mesh had pulled from the sidewall and the loose propylene had not incorporated, foreign body reaction, scar tissue, adipose tissue, infection, pain, and inflammation.Post-operative patient treatment included revision surgery, lysis of adhesions, wound vac, laparoscopic components parts release, open appendectomy, placed in icu, and removal surgery.
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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.(b)(4).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 recurrent ventral incisional hernia.It was reported that after implant, the patient experienced adhesions, recurrence, epigastric pain, difficulty eating, diverticulitis, uti, dyspepsia, gerd, propylene mesh had pulled from the sidewall and the loose propylene had not incorporated, foreign body reaction, scar tissue, adipose tissue, infection, and inflammation.Post-operative patient treatment included revision surgery, lysis of adhesions, wound vac, laparoscopic components parts release, open appendectomy, placed in icu, and removal 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 recurrent ventral incisional hernia.It was reported that after implant, the patient experienced adhesions, recurrence, epigastric pain, difficulty eating, diverticulitis, uti, dyspepsia, gerd, propylene mesh had pulled from the sidewall and the loose propylene had not incorporated, inflammation.Post-operative patient treatment included revision and removal surgery.
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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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