Based on the information provided and not having the sample returned for evaluation, no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date there has been one other complaint reported for this production lot of (b)(4) units released for distribution in october, 2017.The other complaint was reported simultaneously by the same surgeon with the same complaint.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.Remains implanted.
|