Catalog Number PHY3035R |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Ambulation Difficulties (2544); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.This medwatch report is in response to receipt of maude event report mw5067990.
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Event Description
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It was reported that the patient underwent a ventral incisional hernia repair in 2011 and the mesh was used.Six weeks later the patient was sent to pain management due to continuing serious pain.In 2014 the patient was rushed to er due to incarcerated loop of small bowel within ventral hernia and the mesh was replaced with another like mesh on (b)(6) 2014.It was also reported that the patient can barely walk and now diagnosed with psoriatic arthritis.The patient has been on disability since 2012 and had to go to pain management for seven years.Additional information has been requested.
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Manufacturer Narrative
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Details: it was reported that the patient underwent a hernia repair surgeries on (b)(6) 2011 and (b)(6) 2014 and physiomesh was implanted during each surgery.It was reported that the patient experienced an undisclosed adverse event.
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Manufacturer Narrative
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Patient code: (b)(4).It was reported that following insertion the patient experienced small-bowel obstruction and adhesion.
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Manufacturer Narrative
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In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
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Search Alerts/Recalls
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