MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-11-22 for FILIFORM WITH SPIRAL TIP 343105 manufactured by Rusch Manufacturing (uk) Ltd.
[20525533]
Pt went to doctor's office because of urethral stricture. Had been treated for this condition several times prior. On 11/15/96 pt required dilatation for one small distal urethral stricture. Physician performed procedure using filiform and follower. Upon removing the follower, the female thread was still attached to the follower and the rest of the filiform had broken off and was in pt's bladder. Doctor informed pt of what happened due to his dense stricture. Due to density of stricture, physician treated stricture by laser and successfully removed the filiform on 11/19/96 in hosp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010095-1996-00065 |
| MDR Report Key | 52277 |
| Report Source | 05 |
| Date Received | 1996-11-22 |
| Date of Report | 1996-11-22 |
| Date of Event | 1996-11-15 |
| Date Added to Maude | 1996-12-02 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILIFORM WITH SPIRAL TIP |
| Generic Name | FILIFORM |
| Product Code | FBW |
| Date Received | 1996-11-22 |
| Model Number | NA |
| Catalog Number | 343105 |
| Lot Number | E950705 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 52929 |
| Manufacturer | RUSCH MANUFACTURING (UK) LTD |
| Manufacturer Address | CRESSEX INDUSTRIAL ESTATE BUCKINGHAMSHIRE UK HP123NB |
| Baseline Brand Name | FILIFORM WITH SPIRAL TIP |
| Baseline Generic Name | FILIFORM |
| Baseline Model No | * |
| Baseline Catalog No | 343105 |
| Baseline ID | NA |
| Baseline Device Family | FILIFORM AND FILIFORM FOLLOWER |
| Baseline Shelf Life Contained | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-11-22 |