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Catalog Number 0112720 |
Device Problems
Migration or Expulsion of Device (1395); Folded (2630)
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Patient Problems
Pain (1994); Disability (2371)
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Event Date 05/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The information provided alleges that the patient "underwent an additional surgery to revise the positioning of the mesh, which had migrated and folded in on itself".Medical records are not available at this time.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr 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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The following was alleged by the patient's attorney: (b)(6) 2012: the patient underwent surgery for repair of an umbilical hernia.A bard/davol flat mesh, (b)(4), lot number huvi0528 was implanted to repair the hernia defect.(b)(6) 2017: the patient underwent an additional surgery to revise the positioning of the mesh, which had migrated and folded in on itself.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective marlex.
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Search Alerts/Recalls
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