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Catalog Number 0112680 |
Device Problem
Material Disintegration (1177)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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As reported, the bard/davol flat mesh was noted to become damaged when tailoring to fit.The mesh was implanted in the patient, as such unavailable for review.Based on the available information and no sample to evaluate, no conclusion can be made.Review of manufacturing records indicate 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 1038 units released for distribution in october, 2020.Should additional information be provided, a supplemental mdr will be submitted.Not returned.
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Event Description
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As reported, during an open inguinal hernia repair procedure on (b)(6) 2021, the bard/davol flat mesh was noted to be heavy.When sizing, the mesh was friable and small pieces of the mesh crumbled off.As reported, the mesh was used for the procedure.There was no patient injury.
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Event Description
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As reported, during an open inguinal hernia repair procedure on (b)(6) 2021, the bard/davol flat mesh was noted to be heavy.When sizing, the mesh was friable and small pieces of the mesh crumbled off.As reported, the mesh was used for the procedure.There was no patient injury.
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Manufacturer Narrative
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As reported, the bard/davol flat mesh was noted to become damaged when tailoring to fit.The mesh was implanted in the patient, as such unavailable for review.Based on the available information and no sample to evaluate, no conclusion can be made.Review of manufacturing records indicate 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 (b)(6) 2020.H11.Addendum: this supplemental mdr is submitted to populate the date of implant field.Updated fields: b4, d.6a (date of implant), g3, g6, h2, h3, h10, h11.Corrected field: h6 (imdrf annex b code).Should additional information be provided, a supplemental mdr will be submitted.Note: section a through f - the information provided by bd 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 bd.
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Search Alerts/Recalls
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