Based on the information provided an unresorbed suture was assessed by the doctor to be the primary source of the patient's infection.At this time no definitive conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Regarding infection the warning section states, if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.A unresolved infection, however, may require removal of the prosthesis.If additional information is obtained, 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.Remains implanted.
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