Device Problems
Material Erosion (1214); Patient-Device Incompatibility (2682)
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Patient Problems
Erosion (1750); Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
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Event Date 12/19/2011 |
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 the posterior avaulta was inserted in 2009.The patient experienced rectal mesh erosion and had surgery to remove the mesh in 2011 and 2014.
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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 the posterior avaulta was inserted in 2009.The patient experienced rectal mesh erosion and had surgery to remove the mesh in 2011 and 2014.
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Search Alerts/Recalls
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