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Catalog Number 0112720 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Fluid Discharge (2686); Swelling/ Edema (4577)
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Event Date 01/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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As reported, the patient experienced pale yellow effusion and swelling post implant of bard flat mesh.It is reported that with no medical intervention the patient is doing well.Based on the information available, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in september, 2019.
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Event Description
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As reported, during a right inguinal hernia repair procedure, a bard flat mesh was placed to strengthen the posterior wall, the internal opening of the hernia sac was sutured at a high position and the right distal hernia sac was freed.As reported, on (b)(6) 2022, the patient developed a pale yellow effusion and swelling in the right groin area, with scar induration and mild local tenderness.As reported, no medical intervention was performed and the patient is doing well.
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Search Alerts/Recalls
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