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Device Problem
Migration (4003)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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.
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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 underwent recurrent hernia repair surgery on (b)(6) 2018 due to mesh migration.It was reported that the patient experienced adhesions and infection.No additional information was provided.
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Search Alerts/Recalls
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