Based on the information available at this time, no conclusions can be made.
Recurrence is listed in the adverse reaction section of the ifu as a possible complication.
A review of the manufacturing records was performed and found that the lot was manufactured to specification.
If additional information is provided, a supplemental mdr will be submitted.
Note: 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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