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Device Problem
Migration (4003)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Scar Tissue (2060); Hernia (2240); Deformity/ Disfigurement (2360); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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) 2009 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2020.It was reported that the patient experienced adhesions, infection, mesh migration, severe scarring and disfigurement.No additional information was provided.
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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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Search Alerts/Recalls
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