No sample was returned for evaluation.
The lot is unknown; therefore, no review of the device history record could be performed.
The product is manufactured using a controlled and validated manufacturing process.
The product is terminally sterilized by irradiation and has undergone sterilization validation and dose audit studies.
Routine product bioburden monitoring is performed to help safeguard sterility assurance.
Product and packaging inspection stages have been implemented in conjunction with a validated process and documented systems to help safeguard and assure product quality.
An analysis of the labeling confirms the ifu notes that the implant procedure and instrumentation associated with the surgical placement of the product can carry a inherent risk of infection, as do similar urological procedures.
Procedural complications can include transitory irritation at the operative wound site, which may elicit a foreign body response that leads to wound dehiscence, inflammation, infection, or erosion of the implant.
A review of complaint history did not show this type of problem reported before for this product code.
Baseline report previously filed.
It was reported that 2-3 months following, a second urethral sling procedure in 2006, the patient vaginally extruded pieces of the urethral sling material over the course of 1-2 weeks.
The patient was diagnosed during a physical exam.
Vinyl sutures with a continuous stitch were used to close the vaginal incision.
The vaginal mucosa was trimmed prior to closure.
The vaginal mucosa incision was closed loosely.
The patient was given keflex post-op.
The patient was noted as incontinent as of three months later.
No further complications have been reported.