The reporter was unable to provided clarification of the report that the mesh "fell apart." it is reported that the sample is being returned for evaluation; however has not been received to date.At this time no conclusions can be made.If / when the sample is returned and the evaluation has been completed a supplemental mdr will be submitted.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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A review of the manufacturing records found that the product passed all required inspections at both end product and subassembly levels.No manufacturing issues associated to the reported event were found in the reviewed lot.To date this is the only reported complaint for this manufacturing lot of 302 units released for distribution on 01/14/2015.As reported the mesh "fell apart" the contact stated that no additional information could be provided.The sample evaluation found that the positioning straps had been cut from the device and the positioning pocket mesh, was torn.Also noted were severe grasper marks on, and stretching of, the eptfe layer.Additionally, it appears that during attempted implantation of the device the user folded the patch in, towards the eptfe layer, not facing out as is instructed in the ifu.The labeling review found that the ifu states to ¿roll the patch parallel to the opening between the straps with the eptfe side facing out for insertion into the defect.The free or unattached end of the positioning strap is left outside of the body during placement.The positioning strap is manipulated to facilitate the proper positioning of the patch.Gently pull up on the positioning strap, which will allow the patch to flatten itself against the underside of the abdominal wall.¿ the incorrect folding and forces applied during use appears to have led to a combination of factors causing the mesh to tear.This complaint is confirmed for user device interface.
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