MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-05-26 for OLIVE TIPPED FILIFORM 4 FR 342103 * manufactured by Rusch, Inc..
[129240]
On 4/27/99, filoform "broke off into the bladder" during a catheterization procedure. On 5/5/99, device (31 cm gray plastic material) was removed during a cystoscopy procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016401 |
| MDR Report Key | 225394 |
| Date Received | 1999-05-26 |
| Date of Report | 1999-05-14 |
| Date of Event | 1999-04-27 |
| Date Added to Maude | 1999-06-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLIVE TIPPED FILIFORM |
| Generic Name | UROLOGY CATHETERIZATION DEVICE |
| Product Code | FBW |
| Date Received | 1999-05-26 |
| Model Number | 4 FR 342103 |
| Catalog Number | * |
| Lot Number | 911607 INMEE 4 FR |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 218577 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY DULUTH GA 30096 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-05-26 |