|
Catalog Number 0112770 |
Device Problems
Material Erosion (1214); Defective Device (2588); Insufficient Information (3190)
|
Patient Problems
Unspecified Infection (1930); Disability (2371); Bowel Perforation (2668)
|
Event Date 10/13/2013 |
Event Type
Injury
|
Manufacturer Narrative
|
At this time no conclusions can be made.The patient's attorney alleged that the patient had undergone surgical intervention due to hernia recurrence, mesh erosion into the small bowel, infection and was injured permanently and severely; however, no details have been provided.A review of the ifu finds it to be adequate.The fmea review identifies multiple potential adverse patient outcomes associated with surgery/use of the device including mesh erosion, bowel perforation, infection and recurrence.The review identifies controls in place to assess the failure modes and potential harms.Information provided by the patient's attorney is limited and review of the ifu and fmea does not assist in the identification of the root cause of the patient's alleged post-op complications.No manufacturing issues associated to the reported event were found in the reviewed lot.Should additional information be provided a supplemental emdr will be submitted.Not returned.
|
|
Event Description
|
Attorney alleges that the patient underwent surgery for umbilical hernia with bard/davol perfix plug on or about (b)(6) 2001.As reported, the patient is making a claim for an adverse patient outcome against the perfix plug.On or about (b)(6) 2013, the patient underwent a surgery to again repair the umbilical hernia and remove the perfix plug due to mesh erosion into the plaintiff's small bowel and infection.It is alleged that the patient was injured permanently and severely.It is also alleged that the patient has suffered and will continue to suffer physical pain, mental anguish, chronic pain, as well as psychological stress and depression.
|
|
Search Alerts/Recalls
|
|
|