D
Patient 1
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
MAUDE MDR 2644355
- MDR report key
- 2644355
- Report number
- 1018233-2012-00707
- Event key
- 0
- Event type
- 3
- Date received
- 2012-07-10
- 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 POSTERIOR SYNTHETIC SUPPORT SYSTEM | BARD SHANNON LIMITED -3005636544 | OTP | NA | 486200 | HUSD2137R | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-07-10 | 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 SURGICALLY IMPLANTED MATERIALS . THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE REACTIONS: "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. (B)(4).
N
Patient 1
(B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
D
Patient 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS, CHRONIC PELVIC/VAGINAL PAIN, CHRONIC INFECTIONS, URINARY INCONTINENCE, PAINFUL INTERCOURSE, CYSTOCELE/RECURRENCE OF PROLAPSE, DISCOMFORT, PAIN, UNSPECIFIED PSYCHOLOGICAL,EMOTIONAL PROBLEMS (EMOTIONAL CHANGES), DIFFICULTY WITH PHYSICAL ACTIVITIES/WALKING, CHRONIC CONSTIPATION, COLLAGEN DISORDER/DEFICIENCY, IRRITABLE BOWEL SYNDROME, DIVERTICULITIS, DYSPAREUNIA, HERNIA, RECURRENT VAGINAL/BALDER INFECTION, URINARY RETENTION, VAGINAL VAULT PROLAPSE, AND UNSPECIFIED WOUND HEALING PROBLEMS.
N
Patient 1
THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
D
Patient 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED ?FEELING SOMETHING AT THE VAGINAL OPENING THAT ISN?T SUPPOSED TO BE THERE,? VULVA HAD SMALL INCISION WITH DRAINAGE AND SMALL AREA WAS SWOLLEN WITH STITCHES PRESENT, BACTERIAL INFECTION, HIP PAIN, GAS, VAGINAL AREA SWELLING FROM SUTURES ON ANTERIOR VAGINAL WALL, PORTION OF ANTERIOR VAGINAL WALL STRETCHED IN FRONT OF CERVIX THAT REQUIRED SURGICAL INTERVENTION ON (B)(6) 2008, BROWN VAGINAL DISCHARGE WITH SLIGHT ODOR, LEAKING WHEN SNEEZING AND COUGHING, URETHROCELE AND VAGINAL YEAST INFECTION. THE PATIENT ALLEGES STRESS, ANXIETY, DEPRESSION, COLLAGEN DISORDER, CROHN?S DISEASE, IRRITABLE BOWEL, ULCERATIVE COLITIS AND CHRONIC CONSTIPATION.