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Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Surgical procedure (2357)
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Event Type
Injury
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Event Description
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It was reported that a patient underwent a laparoscopic ipom hernia repair procedure on an unknown date and mesh was used.
Approximately four to six weeks post operative, the patient complained of pain.
Approximately six months after the initial procedure, the patient underwent a reoperation.
It was noted that the mesh did not have complete ingrowth.
Also, the bowel was adhered between the mesh and abdominal wall.
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Manufacturer Narrative
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(b)(4).
Conclusion: no conclusion can be drawn at this time.
Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
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Manufacturer Narrative
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(b)(4).
Additional information: narrative - it was reported that a patient underwent a laparoscopic ipom hernia repair procedure on an unknown date and mesh was used.
Approximately four to six weeks post operative, the patient complained of pain.
The patient underwent a reoperation on (b)(4) 2012.
It was noted that the mesh did not have complete ingrowth.
Also, the bowel was adhered between the mesh and abdominal wall.
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Search Alerts/Recalls
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