| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM | C.R. BARD, INC. | FTL | NA | 486100 | HUSC0116 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-08-08 | 0 | 1. R |
Patient 1
IT WAS REPORTED THAT AFTER BEING IMPLANTED WITH THE DEVICE, THE PATIENT HAS HAD RECURRENT BLADDER INFECTIONS AND PAIN IN HER PELVIC REGION, STOMACH, AND BACK. SHE WAS TOLD BY THE PHYSICIAN THAT SHE WOULD HAVE TO UNDERGO ANOTHER CYSTOCELE REPAIR. THE DEVICE REMAINS IMPLANTED AT THIS TIME BUT SHE WILL VISIT ANOTHER PHYSICIAN TO DISCUSS THE IMPLANT.
Patient 1
THE DEVICE REMAINS IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES IN THE SECTION LABELED ADVERSE REACTIONS THAT POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MUCOSAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION, AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, RECTUM, OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE. THE PRODUCT IS RECOMMENDED TO ONLY BE USED BY PHYSICIANS WHO ARE TRAINED IN SURGICAL PROCEDURES AND TECHNIQUES REQUIRED FOR PELVIC FLOOR RECONSTRUCTION AND THE IMPLANTATION OF NONABSORBABLE MESHES. (B)(4).