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Catalog Number 0117321 |
Device Problems
Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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Patient Problems
Neuropathy (1983); Hernia (2240); Disability (2371)
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Event Date 06/30/2017 |
Event Type
Injury
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Manufacturer Narrative
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Currently, it is unknown to what extent the bard/davol 3dmax device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges the patient underwent an additional "repair surgery of hernia and hernia mesh" with partial explant of the bard/davol 3dmax.No medical records have been provided; however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.No lot number has been provided; therefore a review of the manufacturing records is not possible 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.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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Event Description
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The following was alleged by the patient's attorney: on (b)(6) 2015: the patient underwent surgery with an implant of a bard/davol 3dmax mesh for the repair of a right inguinal hernia.It is alleged that in early 2017, the patient started experiencing pain radiating from his abdomen and neuropathy.As reported, the patient's physicians elected for a repair surgery of hernia and hernia mesh.It is alleged that in 2017 the patient underwent repair surgery.As reported, upon entering the abdominal cavity, the surgeon noted that the bard 3dmax mesh has failed and removed part of the mesh.As alleged, as a result of having the "product" implanted in him, the patient has suffered pain, neuropathy, and experienced significant physical pain and suffering.It is alleged the bard/davol 3dmax mesh is defective.
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Search Alerts/Recalls
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