D
Patient 1
THE PT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED BUT NOT YET REC'D.
MAUDE MDR 2707828
- MDR report key
- 2707828
- Report number
- 1018233-2012-00967
- Event key
- 0
- Event type
- 3
- Date received
- 2012-08-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 600
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ANGELA ROBINSON
- 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 | BARD SHANNON LIMITED | OTP | NA | 486100 | HUTD1821 | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-08-17 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE DEVICE REMAINS IMPLANTED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICAL IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE REACTIONS: "POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATES 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." (B)(4).
N
Patient 1
(B)(4).
D
Patient 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED EXPOSED MESH, BLOOD LOSS, LOSS OF SUPPORT, MESH BUNCHED/FOLDED AREA, CYSTOCELE (PROLAPSE), VAGINAL CUFF PROLAPSE, AND REQUIRED NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTION.