Model Number F10244-1218L |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hernia (2240)
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Event Date 02/26/2024 |
Event Type
Injury
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Manufacturer Narrative
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No device problem was found from review of the dhr.The devices in lot ert-22c18 were produced as per established manufacturing procedures.All process specifications including package labeling requirements were met.Hernia recurrence is noted as a potential complication in the instructions for use.There was no evidence to indicate that the device directly caused or contributed to the event.
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Event Description
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It was reported that a patient experienced a hernia recurrence approximately 14 months after ventral/incisional hernia repair.The patient underwent reoperation to repair the hernia recurrence and to remove the originally implanted device.
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Search Alerts/Recalls
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