D
Patient 1
COMPLAINED OF URGENCY, FREQUENCY AND LOW BACK DISCOMFORT. PATIENT TREATED BY PHYSICIAN FOR URINARY TRACT INFECTION BASED ON SYMPTOMS ALONE.
MAUDE MDR 357097
- MDR report key
- 357097
- Report number
- 2130787-2001-00013
- Event key
- 0
- Event type
- 3
- Date of event
- 2001-10-05
- Date received
- 2001-10-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- ROB ANGLIN
- Address
- ONE ROCHESTER MEDICAL DRIVE STEWARTVILLE MN 55976 US
- Phone
- 507-507-5075
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FEMSOFT INSERT | FEMALE TRANSURETHRAL OCCLUSION DEVICE | ROCHESTER MEDICAL CORPORATION | MNG | FEMSOFT INSERT | 71201, 71202 | 53500095 & 53500096 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2001-10-15 | 0 | 1. R |