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Model Number PHSE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Muscle Weakness (1967); Nausea (1970); Vomiting (2144); Hernia (2240); Constipation (3274); 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.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.(b)(4) submitted for adverse event which occurred on (b)(6) 2021.
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Event Description
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It was reported by an attorney that the patient underwent an umbilical hernia repair surgery on (b)(6) 2017 and mesh was implanted.It was reported that the patient underwent robotic ventral hernia repair of recurrent incisional hernia with mesh, mesh revision surgery and omentopexy on (b)(6) 2018.It was reported that the patient underwent revision surgery on (b)(6) 2021.It was reported that the patient experienced abdominal pain, weak spells, nausea, vomiting, constipation and bowel issues.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 11/14/2022.It was reported that the patient underwent mesh removal on (b)(6) 2021 due to recurrent hernia, adhesion, and erosion.
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Search Alerts/Recalls
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