MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-04-18 for FEMSOFT URETHRAL INSERT FEMSOFT INSERT 71203 manufactured by Rochester Medical Corporation.
[441396]
Three femsoft insert devices migrated into the pts bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2006-00001 |
| MDR Report Key | 701070 |
| Report Source | 04 |
| Date Received | 2006-04-18 |
| Date of Report | 2006-04-10 |
| Date of Event | 2006-03-28 |
| Date Mfgr Received | 2006-03-28 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2006-04-20 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PRASHANTH PRABHAKAR |
| Manufacturer Street | ONE ROCHESTER MEDICAL DR. |
| Manufacturer City | STEWARTVILLE MN 55976 |
| Manufacturer Country | US |
| Manufacturer Postal | 55976 |
| Manufacturer Phone | 5075339604 |
| Manufacturer G1 | ROCHESTER MEDICAL CORPORATION |
| Manufacturer Street | ONE ROCHESTER MEDICAL DR. |
| Manufacturer City | STEWARTVILLE MN 55976 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55976 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMSOFT URETHRAL INSERT |
| Generic Name | TRANSURETHRAL OCCLUSIVE DEVICE |
| Product Code | MNG |
| Date Received | 2006-04-18 |
| Model Number | FEMSOFT INSERT |
| Catalog Number | 71203 |
| Lot Number | 53500355 |
| 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 | 690164 |
| Manufacturer | ROCHESTER MEDICAL CORPORATION |
| 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 | 2006-04-18 |