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Catalog Number 0112770 |
Device Problems
Defective Device (2588); Extrusion (2934)
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Patient Problems
Adhesion(s) (1695); Erosion (1750); Disability (2371)
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Event Date 05/16/2014 |
Event Type
Injury
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Manufacturer Narrative
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To date, limited information has been provided.Based on the information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Hernia recurrence, adhesions and extrusion are a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.At this time, no conclusion can be made as to the degree to which the mesh erosion may have caused or contributed to the patient outcome.If additional information is obtained, a supplemental mdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.
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Event Description
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It is alleged by the patient's attorney that on (b)(6) 2008 the patient underwent surgery for repair of a right direct inguinal hernia.As reported, a perfix plug, reference number (b)(4) and lot number hurl0279 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2014 the patient underwent an "additional surgery to repair the hernia defect and remove the extruding mesh which had eroded through the internal ring and caused pelvic adhesions." as reported, on (b)(6) 2015 the patient underwent an "additional surgery to repair a recurrent right lower quadrant incisional hernia." it is alleged by the attorney, the perfix plug used in the patient's hernia repair surgery failed, resulting in much pain and suffering, doctor visits, subsequent procedures and was injured severely and permanently.As alleged, the patient has suffered and will continue to suffer physical pain due to the alleged defective perfix plug.
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Search Alerts/Recalls
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