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Catalog Number 5991015 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date, this is the only reported complaint for this manufacturing lot of 185 units released for distribution in (b)(6) 2020.A review of the manufacturing records was performed and found that the lot was manufactured to specification.When the investigation has been completed, a supplemental mdr will be submitted.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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Event Description
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As reported, during a surgical procedure on (b)(6) 2021, the surgeon opened a bard/davol ventralight st mesh w/ echo ps 2 and noted that the mesh had "unraveled.The procedure was completed using another mesh.There was no reported patient injury.
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Manufacturer Narrative
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At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution in september, 2020.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of device evaluation.Visual evaluation of the returned sample indicates the mesh is unused, and has not been handled with excessive force or rolled for attempted placement into the patient.The echo 2 frame for product code 5991015 is connected to the mesh with four (4) connectors.As received, all four (4) of the connectors are present on the frame, but only two (2) are attached to the mesh.Holes in the mesh, from the connectors, indicate that the two detached connectors were at one point connected to the mesh.Based on the event as reported (out of box), sample evaluation and investigation performed, the most likely root cause of the connector detachment is the event occurred due to handling of unit during the manufacturing process.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.H3 other text : sample evaluated.
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Event Description
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As reported, during a surgical procedure on (b)(6) 2021, the surgeon opened a bard/davol ventralight st mesh w/ echo ps 2 and noted that the mesh had "unraveled.The procedure was completed using another mesh.There was no reported patient injury.
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Search Alerts/Recalls
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