D
Patient 1
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADD'L INFO REC'D, THE PATIENT HAS EXPERIENCED PAIN, EXTRUSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, AND NEUROMUSCULAR PROBLEMS.
MAUDE MDR 3518826
- MDR report key
- 3518826
- Report number
- 1018233-2013-09562
- Event key
- 0
- Event type
- 3
- Date received
- 2013-11-27
- 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
- LISA HALL
- 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 SYNTHETIC SUPPORT SYSTEM ANTERIOR | BARD SHANNON LIMITED -3005636544 | OTP | NA | 486100 | HUTF2232 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-11-27 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE SAMPLE WAS NOT RETURNED. 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. (B)(4).
N
Patient 1
THE SAMPLE WAS NOT RETURNED. 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 EVENTS: 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). 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 VAGINAL NERVE PAIN, LOW BACK PAIN, MIXED, URGE, STRESS URINARY INCONTINENCE, CONSTIPATION, PROLAPSE, LEFT HIP, LEG PAIN, SENSATION OF CRAWLING, USED WALKER (AMBULATION DIFFICULTIES), DISCOMFORT, LEG CRAMPS, DIZZINESS, NIGHT PAIN, LEUKOCYTES IN URINE, URGENCY, FREQUENCY, URINE LEAKAGE, NOCTURIA, ENURESIS, HESITANCY, URINARY TRACT INFECTIONS, DEFECATORY DYSFUNCTION, DOESN'T HAVE STRONG SENSATION OF RECTAL PRESSURE, STRAINS WITH BOWEL MOVEMENTS, SENSATION OF INCOMPLETE EVACUATION, USED DIGITAL MANEUVERS TO ASSIST WITH EVACUATION, ATROPHIC EXTERNAL GENITALIA, URETHROVESICAL JUNCTION HYPERMOBILITY, ATROPHIC VAGINA, SCAR TISSUE, NOCTURNAL ENURESIS, DETRUSOR OVERACTIVITY, URETHRAL HYPERMOBILITY, POLYURIA, EXCESSIVE URINE PRODUCTION, CHEST PAIN, SLEEP APNEA, B COMPLEX DEFICIENCIES, CHRONIC PAIN SYNDROME, MYALGIA, MYOSITIS (INFLAMMATION), VITAMIN D DEFICIENCY, DIARRHEA, MONONEURITIS, INSOMNIA (SLEEP DISTURBANCES), CONTUSION (BRUISE), IRON DEFICIENCY ANEMIA, DIZZINESS, EDEMA, HEADACHES, CARDIAC DYSRHYTHMIA AND NONSURGICAL INTERVENTIONS.