Model Number UMM3 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient experienced lysis of adhesion, infected abdominal wall, abscess formation and recurrence hernia.It was reported that the patient underwent removal of mesh on (b)(6) 2016.It was reported that the patient previously underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted which is captured in a separate file.
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Manufacturer Narrative
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Date sent to the fda: 12/22/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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