MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-10-04 for FEMSOFT INSERT * 71201 manufactured by Rochester Medical Corporation.
[181714]
Adult female reported to clinical investigator for 3 year evaluation. Urine culture + klebsiella, asymptomatic. Treated with septra ds one bid x 7 days, dc device until meds gone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2000-00012 |
| MDR Report Key | 299275 |
| Report Source | 05 |
| Date Received | 2000-10-04 |
| Date of Report | 2000-09-15 |
| Date of Event | 2000-09-05 |
| Date Mfgr Received | 2000-09-12 |
| Device Manufacturer Date | 1998-02-01 |
| Date Added to Maude | 2000-10-11 |
| 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 DRIVE |
| 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 | 2000-10-04 |
| Model Number | * |
| Catalog Number | 71201 |
| Lot Number | 1M0143 |
| 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 | 289694 |
| Manufacturer | ROCHESTER MEDICAL CORPORATION |
| Manufacturer Address | ONE ROCHESTER MEDICAL DRIVE STEWARTVILLE MN 55976 US |
| Baseline Brand Name | FEMSOFT INSERT |
| Baseline Generic Name | TRANSURETHRAL FEMALE URINARY OCCLUSION DEVICE |
| Baseline Catalog No | 71201 |
| Baseline ID | 16 FR. 3.5 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 | 2000-10-04 |