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Catalog Number 0112720 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Disability (2371)
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Event Date 04/18/2006 |
Event Type
Injury
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Manufacturer Narrative
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To date, limited information has been provided.
Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.
Regarding infection, the warning section of the ifu states "if one develops, treat the infection aggressively.
Consideration should be given regarding the need to remove the mesh.
An unresolved infection may require removal of the device.
" review of the device history records found lot was manufactured to specification.
No anomalies identified.
If additional information is obtained, a supplemental mdr will be submitted.
Not returned.
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Event Description
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It is alleged by the patients attorney that on (b)(6) 2006, the patient underwent surgery for repair of a large epigastric hernia.
As reported, a bard/davol marlex, (b)(4), lot number 43kpd179 was implanted to repair the hernia defect.
It is alleged that on (b)(6) 2006, the patient underwent an additional surgery to remove infected hernia mesh.
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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