Device Problems
Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)
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Patient Problems
Hemorrhage/Bleeding (1888); Pain (1994); Discharge (2225); Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
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Event Description
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It was reported that in 2011 the patient allegedly experienced pain, bleeding, and discharge.The patient had a vaginal mesh inserted in 2010 and was found to have a large posterior vaginal mesh extrusion, which required surgery to remove the mesh.
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Manufacturer Narrative
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The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the unknown avaulta - bard product ifus are found to be adequate based on past reviews.
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Event Description
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It was reported that in 2011 the patient allegedly experienced pain, bleeding, and discharge.The patient had a vaginal mesh inserted in 2010 and was found to have a large posterior vaginal mesh extrusion, which required surgery to remove the mesh.
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Search Alerts/Recalls
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