MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-04-30 for WHISTLE TIP URETERAL CATHETER 331105 manufactured by Rusch Inc..
[21247080]
It is alleged that once the catheter was inserted, it fell apart. All pieces were removed from the pt's bladder without incident. No further impact or injury to the pt is reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1999-00035 |
| MDR Report Key | 221483 |
| Report Source | 06 |
| Date Received | 1999-04-30 |
| Date of Report | 1999-04-29 |
| Date of Event | 1999-04-27 |
| Date Mfgr Received | 1999-04-29 |
| Date Added to Maude | 1999-05-05 |
| 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 | WHISTLE TIP URETERAL CATHETER |
| Generic Name | URETERAL CATHETER |
| Product Code | FGF |
| Date Received | 1999-04-30 |
| Model Number | NA |
| Catalog Number | 331105 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 214777 |
| Manufacturer | RUSCH INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US |
| Baseline Brand Name | WHISTLE TLP CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 331105 |
| Baseline ID | NA |
| Baseline Device Family | URETERAL CATHETER |
| 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 | 1999-04-30 |