As requested by the fda, we have made note of the product code.The product code listed is not necessarily the product code assigned to the device 510(k), but rather the product code that seems the most appropriate based on the surgical procedure in which the product was implanted.
|
The patient was reportedly implanted with an unspecified cook graft(s) to treat her pelvic organ prolapse and/or stress urinary incontinence.No additional details were provided.The patient and her attorney have alleged that as a result of this/these product(s) being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.
|