No medical records or no medical images have been made available to the manufacturer.The device has not been returned to the manufacturer for evaluation.As the lot number for the device was provided, a review of the device history records is currently being performed.The investigation of the reported event is currently underway.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.
|
Manufacturing review: a manufacturing review was conducted and the reported lot met all release criteria.Visual inspection: the sample was not returned; therefore, a visual inspection could not be performed.Functional/performance evaluation: the sample was not returned; therefore, a functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation.Per the instructions for use, the device contains three resorbable polyglycolic acid (pga) pads and one polyethylene glycol (peg) push pellet.However, based on the available information, the definitive root cause is unknown.It is unknown whether procedural issues at the facility contributed to the event.Labeling review: the current senomark ultra breast biopsy marker instructions for use (ifu) states: the senomark® ultra breast tissue marker consists of a disposable applicator containing: ¿ - 3 resorbable polyglycolic acid (pga) pads that are essentially resorbed in approximately 12 weeks.The center pad contains a titanium or biodur¿ 108 wireform with an interwoven polyvinyl alcohol (pva) polymer for permanent ultrasound enhancement.Please note the (pva) polymer is not resorbed.¿ - 1 polyethylene glycol (peg) push pellet.Precautions: - this product should only be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of breast tissue marker placement.Complications: - complications may occur at any time during or after the procedure.Potential complications of breast tissue marker placement may include, but are not limited to: hematoma, hemorrhage, infection, adjacent tissue injury and pain.How supplied - the senomark® ultra breast tissue marker is provided sterile and non-pyrogenic unless the package has been opened or damaged.Sterilized by using irradiation.For single use only.Do not reuse.Do not resterilize.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.
|