The sample was visually examined with unaided eye and under magnification.The mesh was found have a tear at the outer seal weld to the left of the positioning pocket.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of 174 units.As reported this was not an out of the box condition.The damage likely inadvertently occurred during implantation with manipulation when it was noticed.The damage is consistent with user/device interface and no manufacturing anomalies were found.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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