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Model Number PML |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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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 a ventral hernia repair surgery on (b)(6) 2003 and mesh was implanted.It was reported that the patient underwent a ventral hernia repair surgery on (b)(6) 2009, (b)(6) 2014 and unk date and mesh was implanted.It was reported that the patient experienced mesh adhesion, infection, pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, and hernia recurrence.The patient had a previous mesh implanted on unk date and another mesh implanted on (b)(6) 2002 which are captured in separate files.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.Mwr# (b)(4) submitted for adverse event which occurred on (b)(6) 2009.Mwr# (b)(4) submitted for adverse event which occurred on (b)(6) 2014.Mwr# (b)(4) submitted for adverse event which occurred on unk date.
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Event Description
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It was reported by an attorney that the patient underwent a ventral hernia repair surgery on (b)(6) 2003 and mesh was implanted.It was reported that the patient underwent a ventral hernia repair surgery on (b)(6) 2009, (b)(6) 2014 and unk date and mesh was implanted.It was reported that the patient experienced mesh adhesion, infection, pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, and hernia recurrence.The patient had a previous mesh implanted on unk date and another mesh implanted on (b)(6) 2002 which are captured in separate files.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.Mwr# (b)(4) submitted for adverse event which occurred on (b)(6) 2009.Mwr# (b)(4) submitted for adverse event which occurred on (b)(6) 2014.Mwr# (b)(4) submitted for adverse event which occurred on unk date.
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Manufacturer Narrative
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Date sent to the fda: 02/16/2022.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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