MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-09-01 for FEMSOFT INSERT * 71203 manufactured by Rochester Medical Corp..
[148927]
Adult pt called to report migration of insert on 8/4. Went to hospital er on 8/5 and had cystoscopic retrieval of the device. Pt reports no residual effects. This pt had migration on previous occasion. At that time pt reported "tucking" external retainer of device into meatus. Pt was advised against this practice and informed it could predispose to migration. Also instructed at that time to see md for eval of size and insertion technique. Insertion technique not verified by md. Md did report correct size device was used. At this time pt again reported "pushing up on" external retainer during insertion after removal of applicator. Again instructed to not advance any part of the external retainer into the urethra. Also again advised to see md for eval of insertion technique and device sizing. The md was contacted on 2 occasions to obtain further info but did not respond. The complaint was closed after no follow up obtained from md.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2000-00010 |
| MDR Report Key | 294285 |
| Report Source | 04 |
| Date Received | 2000-09-01 |
| Date of Report | 2000-08-08 |
| Date of Event | 2000-08-04 |
| Date Mfgr Received | 2000-08-08 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2000-09-07 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 2000-09-01 |
| Model Number | * |
| Catalog Number | 71203 |
| Lot Number | 53500018 |
| ID Number | * |
| Device Expiration Date | 2002-01-24 |
| 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 | 284874 |
| 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 | 71203 |
| Baseline ID | 20 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 | 2000-09-01 |