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Catalog Number PHY2030R |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Fistula (1862); Hernia (2240)
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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.(b)(4) represents the adverse event which occurred on (b)(6) 2018.(b)(4) represents the adverse event which occurred on (b)(6) 2018.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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Event Description
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It was reported by an attorney that the patient underwent a hernia repair procedure on(b)(6) 2012 and mesh was implanted.It was reported that patient underwent revision of mesh on (b)(6) 2018 due to recurrent hernia, fistula, abscess, erosion and abdominal wound.No additional information was provided.
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Search Alerts/Recalls
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