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Catalog Number PHY1520V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Hernia (2240); Discomfort (2330)
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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 product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.
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Event Description
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It was reported by an attorney that the patient underwent a hernia repair procedure on (b)(6) 2013 and mesh was implanted.It was reported that the patient experienced hernia recurrence, abdominal pain, adhesions, discomfort and sharp pain through scar tissue following surgery.It was reported that the patient underwent mesh revision on (b)(6) 2015 and mesh removal on (b)(6) 2017.No additional information was provided.
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Search Alerts/Recalls
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