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Catalog Number 0117009 |
Device Problem
Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/13/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The information provided regarding the reported event is limited.Additional information has been requested.The return of the sample was also requested and is expected to be returned to davol for evaluation.A photo of the sample was provided.The photo is of two strips of mesh side by side that appear to be connected at one end.A review of the manufacturing records was performed and found that the lot was manufactured to specification.The precautions section of the ifu states, "intact bard soft mesh exhibits high burst and tensile strength.However, when custom tailoring in special circumstances where excessive force is placed on the mesh, the following guidelines may be helpful: when cutting a notch in the mesh, a v-shape with a radiused point will withstand more force than a v-shape which comes to a sharp point." the provided photo is of poor quality and based on the photo evaluation and the limited information that has been provided to date, we are unable to determine a cause for the condition of the mesh in the photo.If/when the sample is returned and evaluated, a supplemental mdr will be submitted to document the results of the sample evaluation.The information provided by (b)(6) 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.
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Event Description
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The following was reported to davol: during set up for the procedure, while being fixed with suture, the bard soft mesh ripped across its entire length in 2 pieces.As reported, the issue presented in set up prior to implant and there was no patient injury.
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Manufacturer Narrative
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This is an addendum to the initial mdr to document the return of the sample and to report the findings of the sample evaluation.As was reported visual examination of the sample shows that the mesh was torn.The sample condition is consistent with the event as reported.No anomalies were identified on the sample.Evaluation indicates the damage was likely caused by user device interface.To date this is the only reported complaint of its kind for this manufacturing lot of (b)(4) units released for distribution on 07/29/2015.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.
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Event Description
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This is an addendum to the initial mdr as additional information was provided and the sample has been return: it is reported that during a laparoscopic inguinal bilateral hernia repair procedure, while being fixed with suture the bard soft mesh ripped across the entire length in two pieces.It is reported that no undue force was applied to the mesh when fixating with suture.To complete the procedure the surgeon used another bard soft mesh from the same lot on one side and another manufacturers' mesh on the other side.As reported prior to fixing the suture the mesh had been modified (cut/shaped) by the surgeon.
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Search Alerts/Recalls
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