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Catalog Number UNKAA030 |
Device Problems
Material Erosion (1214); Defective Device (2588); Material Deformation (2976)
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Patient Problems
Adhesion(s) (1695); Erosion (1750); Disability (2371)
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Event Type
Injury
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Manufacturer Narrative
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At this time no conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention for mesh explant, erosion, hardening, adhesions, hernia recurrence, scarring, chronic pain and permanent injury; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.Not returned.
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Event Description
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Attorney alleges that the patient was implanted with an unspecified bard mesh (bard flat mesh) and three unspecified non bard/ davol meshes.As reported, the patient had a hernia and or/ recurrent hernias that required surgical intervention for repair.It is alleged that following the surgeries, the patient experienced pain in the abdominal region.It is alleged that the surgical operations to remove the eroded surgical mesh spanned considerable periods of time, and it is unclear whether the all of the remnants of the mesh systems had been removed.It is also alleged that the patient suffered debilitating injuries, including; mesh erosion, hardening, chronic pain and adhesions, which required and will continue to require healthcare services.It is alleged that the mesh systems were defective, had eroded and caused dense scarring.The patient had suffered and would continue to suffer chronic debilitating pain, severe and permanent injuries and experienced emotional distress.
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Search Alerts/Recalls
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