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Catalog Number 0117070 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Pain (1994); Discomfort (2330)
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Event Date 10/07/2015 |
Event Type
Injury
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Event Description
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As reported, during an left inguinal hernia repair procedure on (b)(6) 2015, the patient was implanted with a bard/davol perfix light plug.It was reported that post-implant, the patient experienced pain, "feeling of mesh out of place" and abdominal discomfort.It was also reported that the patient has been dealing with gastroesophageal reflux disease (gerd) for many years.As reported, a ct scan, ultrasound, and mri was performed and there were no findings.The patient has been taking pain medication.
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Manufacturer Narrative
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As reported, post-implant of the perfix plug light, the patient has experienced chronic pain and abdominal discomfort.Patient has undergone multiple tests with no findings and continues to seek medical assistance.Based on the available information, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.Note, the date of event is estimated, based on the information provided.Not returned - remains implanted.
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Search Alerts/Recalls
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