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Catalog Number UNKAA086 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
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Patient Problems
Pain (1994); Disability (2371); Ambulation Difficulties (2544)
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Event Type
Injury
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Manufacturer Narrative
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Based on the information provided there is no connection that can be at this time between the allegations made by the patient's attorney and any problem with the bard/davol device used to treat the patient's hernia.The patient's attorney did not allege a specific device failure and no medical records have been provided.Based on the information as provided, the implant location of the bard ventralex st mesh is unclear.With the limited information reported at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records could not be conducted.Should additional information be provided, a supplemental emdr will be submitted.This file represents the bard ventralex st mesh , an additional emdr has been submitted to document the alleged implant of the bard perfix plug.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: on (b)(6) 2014 - the patient underwent the repair of the left inguinal hernia with mesh, plug and patch technique.The attorney alleges during the implant procedure the patient was implanted with a bard/davol perfix plug and a bard/davol ventralex st mesh.The attorney for the patient alleges the patient has experienced severe and permanent bodily injuries, including but not limited to excruciating abdominal pain and swelling, difficulty walking and physical pain and alleges the patient will have to undergo additional surgery to "remove and/or repair the damage and injuries caused by the products." the attorney further alleges the products are defective and the patient to have suffered future loss of enjoyment of life, permanent injury, permanent scarring and disfigurement.
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Search Alerts/Recalls
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