D
Patient 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED STRESS URINARY INCONTINENCE (SUI), UNSPECIFIED PAIN, UNSPECIFIED INFECTION, UNSPECIFIED BOWEL PROBLEMS, UNSPECIFIED RECURRENCE, AND DYSPAREUNIA.
MAUDE MDR 3940393
- MDR report key
- 3940393
- Report number
- 1018233-2014-00155
- Event key
- 0
- Event type
- 3
- Date received
- 2014-06-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 600
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CHRISTY LEWIS
- 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 | TEGRESS URETHRAL IMPLANT | BARD PUERTO RICO | FBK | NA | 653001 | 43KPH001 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-06-18 | 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).