MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-05-04 for FILIFORM WITH SPIRAL TIP, PHILLIPS CATHETER FOLLOWER 343104, 346126 manufactured by Rusch Inc..
[129042]
It is reported that filiform and follower became separated upon removal from the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1999-00037 |
| MDR Report Key | 222416 |
| Report Source | 06 |
| Date Received | 1999-05-04 |
| Date of Report | 1999-05-04 |
| Date of Event | 1999-04-16 |
| Date Mfgr Received | 1999-04-27 |
| Date Added to Maude | 1999-05-12 |
| 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 | FILIFORM WITH SPIRAL TIP, PHILLIPS CATHETER FOLLOWER |
| Generic Name | FILIFORM AND FOLLOWER |
| Product Code | FBW |
| Date Received | 1999-05-04 |
| Returned To Mfg | 1999-04-27 |
| Model Number | NA |
| Catalog Number | 343104, 346126 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 215697 |
| Manufacturer | RUSCH INC. |
| Manufacturer Address | 2450 MEADOWBROOK PARKWAY DULUTH GA 30096 US |
| Baseline Brand Name | FILIFORM WITH SPIRAL TIP, PHILLIPS CATHETER FOLLOWER |
| Baseline Generic Name | FILIFORM AND FOLLOWER |
| Baseline Model No | NA |
| Baseline Catalog No | 343104, 346126 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-05-04 |