MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-05-16 for OLIVE TIP FILIFORM 342104 manufactured by Rusch, Inc..
[16786854]
It was reported that while being removed, the tip of the filiform became detached. Cystoscopy was performed and the tip was removed surgically.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2429473-1999-00040 |
MDR Report Key | 223699 |
Report Source | 06 |
Date Received | 1999-05-16 |
Date of Report | 1999-05-13 |
Date of Event | 1999-04-27 |
Date Mfgr Received | 1999-05-12 |
Date Added to Maude | 1999-05-20 |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | OLIVE TIP FILIFORM |
Generic Name | FILIFORM |
Product Code | FBW |
Date Received | 1999-05-16 |
Model Number | NA |
Catalog Number | 342104 |
Lot Number | E911607 |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 216941 |
Manufacturer | RUSCH, INC. |
Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US |
Baseline Brand Name | OLIVE TIP FILIFORM |
Baseline Generic Name | FILIFORM |
Baseline Model No | NA |
Baseline Catalog No | 342104 |
Baseline ID | NA |
Baseline Device Family | FILIFORM |
Baseline Shelf Life Contained | * |
Baseline Shelf Life [Months] | * |
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. Other | 1999-05-16 |