MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05 report with the FDA on 2002-07-19 for FEMSOFT URETHRAL INSERT FEMSOFT INSERT 71201 manufactured by Rochester Medical Corp..
[21614024]
Patient reported having symptoms of uti (pain and burning with urination) in fall 2001. Patient did not notify clinical study coordinator until next scheduled followup visit. Symptoms resolved with macrodantin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2002-00003 |
| MDR Report Key | 405746 |
| Report Source | 02,05 |
| Date Received | 2002-07-19 |
| Date of Report | 2002-07-18 |
| Date of Event | 2002-04-09 |
| Date Mfgr Received | 2002-07-15 |
| Device Manufacturer Date | 2000-12-01 |
| Date Added to Maude | 2002-07-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROB ANGLIN |
| Manufacturer Street | ONE ROCHESTER MEDICAL DRIVE |
| Manufacturer City | STEWARTVILLE MN 55976 |
| Manufacturer Country | US |
| Manufacturer Postal | 55976 |
| Manufacturer Phone | 5075339613 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMSOFT URETHRAL INSERT |
| Generic Name | FEMALE TRANSURETHRAL OCCLUSION DEVICE |
| Product Code | MNG |
| Date Received | 2002-07-19 |
| Model Number | FEMSOFT INSERT |
| Catalog Number | 71201 |
| Lot Number | 53500047 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 394738 |
| Manufacturer | ROCHESTER MEDICAL CORP. |
| Manufacturer Address | ONE ROCHESTER MEDICAL DR. STEWARTVILLE MN 55976 US |
| Baseline Brand Name | FEMSOFT URETRAL INSERT |
| Baseline Generic Name | FEMALE TRANSURETHRAL OCCLUSION DEVICE |
| Baseline Model No | FEMSOFT INSERT |
| Baseline Catalog No | 72202 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-07-19 |