D
Patient 1
IT WAS REPORTED THAT AFTER BEING IMPLANTED WITH THE DEVICE, THE PATIENT HAS HAD MULTIPLE COMPLICATIONS INCLUDING BUT NOT LIMITED TO BACK PAIN, HIP PAIN, TROUBLE AND PAIN URINATING, VAGINAL SORES, AND DISCOMFORT DURING SEX.
MAUDE MDR 2158295
- MDR report key
- 2158295
- Report number
- 1018233-2011-00151
- Event key
- 0
- Event type
- 3
- Date received
- 2011-06-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- CHATERYL WASHINGTON
- Address
- 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| 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 | HUSK0698 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-06-27 | 0 | 1. R |
Event Narratives#
N
Patient 1
BARD HAS MADE THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER WITHOUT ANY SUCCESS. THE DEVICE REMAINS IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE LOT NUMBER PROVIDED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. 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).