| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD TEGRESS URETHRAL BULKING AGENT | URETHRAL BULKING AGENT | C.R. BARD, INC. | LNM | NA | 653001 | UNK | Y | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2006-09-22 | 0 | 1. R |
Patient 1
THIS MDR IS BEING FILED AS EXPOSED IMPLANT MATERIAL. IT WAS REPORTED THAT FOLLOWING THE INITIAL TREATMENT IN 2006 WITH A URETHRAL BULKING IMPLANT, THE PATIENT SHOWED SOME IMPROVEMENT, BUT EXPERIENCED RECURRENT URINARY TRACT INFECTIONS. A CYSTOSCOPY WAS PERFORMED AND A STONE WAS NOTED IN THE BLADDER WITH IMPLANT MATERIAL NOTED EXPOSED ON THE RIGHT SIDE OF THE BLADDER NECK AREA. NO FURTHER COMPLICATIONS BEEN REPORTED.
Patient 1
THE LOT NUMBER IS UNK THEREFORE NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. THE INSTRUCTIONS FOR USE STATES THAT THE DEVICE FORMS A COHESIVE, SPONGY MASS THAT SERVES TO BULK SURROUNDING TISSUE AND IS NOT SUBJECT TO ABSORPTION OR ENZYMATIC BREAKDOWN WITHIN THE BODY. THE LOW VISCOSITY OF THE IMPLANT SOLUTION AND THE COHESIVE MASS OF THE RESULTING IMPLANT REQUIRE SPECIFIC ATTENTION TO THE INJECTION SITE, NEEDLE ORIENTATION, DEPTH OF NEEDLE PLACEMENT, RATE OF INJECTION, AND INJECTION VOLUME, IN ORDER TO ACHIEVE THE HIGHEST RATE OF SUCCESS. DURING THE COURSE OF THE CLINICAL INVESTIGATION, SOME SUBJECTS RECEIVING THE URETHRAL IMPLANT TREATMENT EXPERIENCED EXPOSED BULKING MATERIAL IN THE URETHRAL MUCOSA. EXPOSED MATERIAL WAS ASSOCIATED WITH SHALLOW PLACEMENT AND INJECTION PROXIMAL TO THE BLADDER NECK. OVER TIME, THE URETHRA HEALED SPONTANEOUSLY AS THE MUCOSAL SURFACE RE-EPITHELIALIZED. A PHYSICIAN MAY CHOOSE TO REMOVE EXPOSED MATERIAL CYSTOSCOPICALLY WITH GRASPERS OR FORCEPS TO FACILITATE HEALING. THE IFU INSTRUCTS THE USER: THE UNIQUE CHARACTERISTICS OF THE BULKING MATERIAL REQUIRE INJECTION TECHNIQUES THAT MAY DIFFER SLIGHTLY FROM TECHNIQUES EMPLOYED WITH ALTERNATIVE BULKING AGENTS. CONTRAINDICATIONS INCLUDE PATIENTS WITH THE FOLLOWING CONDITIONS: ACUTE CYSTITIS, URETHRITIS, OTHER ACUTE OR CHRONIC GENITOURINARY TREAT INFECTIONS, OR FRAGILE URETHRAL MUCOSAL LINING.