MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-03-31 for FEMSOFT INSERT * 72202 manufactured by Rochester Medical Corp..
[191594]
Pt seen by md for unrelated reason. Routine urinalysis/urine culture positive for e. Coli. Pt was asymptomatic. Md elected to treat empirically. This is a clinical study pt. By protocol, pt would not have been treated by the study investigator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2000-00002 |
| MDR Report Key | 271954 |
| Report Source | 05 |
| Date Received | 2000-03-31 |
| Date of Report | 2000-02-29 |
| Date of Event | 2000-02-04 |
| Date Mfgr Received | 2000-02-29 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 2000-04-05 |
| 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 | PATRICK GORA |
| Manufacturer Street | ONE ROCHESTER MEDICAL DR |
| Manufacturer City | STEWARTVILLE MN 55976 |
| Manufacturer Country | US |
| Manufacturer Postal | 55976 |
| Manufacturer Phone | 5075339605 |
| 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 INSERT |
| Generic Name | FEMALE TRANSURETHRAL OCCLUSION DEVICE |
| Product Code | MNG |
| Date Received | 2000-03-31 |
| Model Number | * |
| Catalog Number | 72202 |
| Lot Number | 2L0126 |
| 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 | 263273 |
| Manufacturer | ROCHESTER MEDICAL CORP. |
| Manufacturer Address | ONE ROCHESTER MEDICAL DR. STEWARTVILLE MN 55976 US |
| Baseline Brand Name | FEMSOFT INSERT |
| Baseline Generic Name | TRANSURETHRAL FEMALE URINARY OCCLUSION DEVICE |
| Baseline Catalog No | 72202 |
| Baseline ID | 18 FR. 4.5 CM |
| Baseline Device Family | FEMSOFT INSERT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9900 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-03-31 |