MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-07-01 for CONE TIP URETERAL CATHETER 334112 manufactured by Rusch Mfg. Uk, Ltd..
[20517542]
Tip fell during use. No injury to pt. No other info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010092-1998-00035 |
| MDR Report Key | 175852 |
| Report Source | 06 |
| Date Received | 1998-07-01 |
| Date of Report | 1998-07-01 |
| Date Mfgr Received | 1998-06-25 |
| Date Added to Maude | 1998-07-09 |
| 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 | CONE TIP URETERAL CATHETER |
| Generic Name | UROLOGICAL DEVICE |
| Product Code | FGF |
| Date Received | 1998-07-01 |
| Model Number | NA |
| Catalog Number | 334112 |
| Lot Number | E961314 |
| ID Number | NA |
| Operator | NO INFORMATION |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 170990 |
| Manufacturer | RUSCH MFG. UK, LTD. |
| Manufacturer Address | PORTADOWN RD. LURGAN CO ARMAGH NORTHERN IRELAND EI BT66 8RD |
| Baseline Brand Name | CONE TIP URETERAL CATHETER |
| Baseline Generic Name | URETERAL CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 334112 |
| Baseline ID | NA |
| Baseline Device Family | URETERAL CATHETERS |
| Baseline Shelf Life [Months] | NA |
| 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 | 1998-07-01 |