MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-01-05 for URETHRAL FILIFORM 342105 manufactured by Rusch Manufacturing (uk) Ltd..
[145678]
It was reported that the filiform was inserted into the pt with severe urethral stricutures. Filiform broke off at the juncture of the tip and attachment with the follower. Unable to retrieve due to urethral edema, even with cystopscopy. Plan gradual repeated dilations to open urethra enough to remove, once urethra is healed enough.
Patient Sequence No: 1, Text Type: D, B5
[192415]
Pt underwent cytoscopy on 10/12/1999. Filiform removed without complication. No residual problems from event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010095-1999-00108 |
| MDR Report Key | 257681 |
| Report Source | 05 |
| Date Received | 2000-01-05 |
| Date of Report | 1999-12-28 |
| Date of Event | 1999-08-31 |
| Date Mfgr Received | 1999-12-28 |
| Date Added to Maude | 2000-01-10 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KATRINA HALBIG |
| Manufacturer Street | 2450 MEADOWBROOK PKWY |
| Manufacturer City | DULUTH GA 30096 |
| Manufacturer Country | US |
| Manufacturer Postal | 30096 |
| Manufacturer Phone | 7706230816 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URETHRAL FILIFORM |
| Generic Name | FILIFORM WITH STRAIGHT TIP |
| Product Code | FBW |
| Date Received | 2000-01-05 |
| Model Number | NA |
| Catalog Number | 342105 |
| Lot Number | E913117 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 249538 |
| Manufacturer | RUSCH MANUFACTURING (UK) LTD. |
| Manufacturer Address | HALIFAX ROAD CRESSEX INDUSTRIAL ESTATE HIGH WYCOMBE, BUCKS UK HP12 3NB |
| Baseline Brand Name | URETHRAL FILIFORM |
| Baseline Generic Name | FILIFORM WITH STRAIGHT TIP |
| Baseline Model No | NA |
| Baseline Catalog No | 342105 |
| Baseline ID | 992440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-01-05 |