Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.The patient's attorney did not allege any specific device failure and a sample was not returned for further evaluation.No lot number was provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided by the patient's attorney, no conclusions can be made between the bard/davol device used to treat the patient and any problem with the device.Should additional information be provided, a supplemental emdr will be submitted.Note: the actual date of removal surgery is unknown, as reported by the patient's attorney "in 2016 [the patient] underwent removal surgery." therefore we are using (b)(6) 2016 as a date of explant.Note: 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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The following was alleged by the patient's attorney: on (b)(6) 2007- the patient was implanted with a bard composix mesh at for the repair of an incarcerated ventral hernia.On ni/ni/2016- the patient underwent removal surgery.Upon entering the abdominal cavity, the patient's surgeon noted that the bard composix mesh had failed and removed the mesh.As alleged, currently, the patient is experiencing "abdominal pain, bloating, and is limited in her mobility due to the bard composix mesh." as reported, the patient has "suffered pain, neuropathy, scarring, and intestinal blockage and will continue to suffer physical pain from her hernia mesh injury." the patient's attorney alleges that "as a result of having the bard composix mesh implanted, the patient has experienced significant physical pain and suffering, has sustained permanent injury, has undergone medical treatment, and will likely undergo further medical treatment and procedures.".
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