MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2000-12-29 for FEMSOFT URETHRAL INSERT FEMSOFT INSERT 71203 manufactured by Rochester Medical Corp..
[207261]
In 12/2000 pt reported possible migration. At that time pt was evaluated by dr who reported that no device was found during a cystoscopy. On 4/2001 pt phoned to notify that pt underwent bladder suspension at clinic in 3/2001 by another dr. During the surgery a femsoft device was discovered in their bladder. A copy of the operative report provided by the pt indicated that the suburethral sling had already been placed when the femsoft was detected by cystoscopy in the bladder. The device was removed via a small cystotomy.
Patient Sequence No: 1, Text Type: D, B5
[215107]
Pt believed that a femsoft device had migrated. The pt was seen by a urologist who performed a cystoscopy and pelvic examination. All findings were within normal limits and no device was recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2000-00020 |
| MDR Report Key | 311234 |
| Report Source | 04,05 |
| Date Received | 2000-12-29 |
| Date of Report | 2000-12-29 |
| Date of Event | 2000-12-22 |
| Date Mfgr Received | 2000-12-22 |
| Device Manufacturer Date | 2000-05-01 |
| Date Added to Maude | 2001-01-10 |
| 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 DR |
| 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 | 2000-12-29 |
| Model Number | FEMSOFT INSERT |
| Catalog Number | 71203 |
| Lot Number | 53500043 |
| ID Number | * |
| Device Expiration Date | 2002-05-30 |
| 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 | 301041 |
| 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 | 2000-12-29 |