| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM | C.R. BARD, INC. | FTL | NA | 486200 | HUSG1039 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-05-14 | 0 | 1. R |
Patient 1
IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE MESH IMPLANTED THAT SHE HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY AND PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.
Patient 1
THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NOTHING WAS FOUND THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES IN THE ADVERSE REACTIONS SECTION: "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 INSTRUCTIONS FOR USE STATES UNDER PRECAUTIONS: "THE MESH SHOULD ONLY BE USED BY PHYSICIANS WHO ARE TRAINED IN THE SURGICAL PROCEDURES AND TECHNIQUES REQUIRED FOR PELVIC FLOOR RECONSTRUCTION AND THE IMPLANTATION OF NONABSORBABLE MESHES. ACCEPTABLE SURGICAL PRACTICES SHOULD BE FOLLOWED FOR THE MANAGEMENT OF INFECTED OR CONTAMINATED WOUNDS." (B) (4).