MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-06-24 for STRAIGHT TIP FILIFORM 342103 manufactured by Rusch Inc..
[20157447]
It was reported that the filiform broke off in the bladder during a catherization procedure. The broken segment was subsequently removed from the patients bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1999-00059 |
| MDR Report Key | 228911 |
| Report Source | 00 |
| Date Received | 1999-06-24 |
| Date of Report | 1999-06-23 |
| Date of Event | 1999-04-27 |
| Date Mfgr Received | 1999-06-18 |
| Date Added to Maude | 1999-06-29 |
| 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 | STRAIGHT TIP FILIFORM |
| Generic Name | FILIFORM |
| Product Code | FBW |
| Date Received | 1999-06-24 |
| Model Number | NA |
| Catalog Number | 342103 |
| Lot Number | 911607 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| 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. Required No Informationntervention | 1999-06-24 |