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 CONE TIP URETERAL CATHETER 334108 manufactured by Rusch, Inc..
[16267446]
It is reported that there was a defect on the cone tip, which made it rough. This roughness allegedly caused pain to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1999-00038 |
| MDR Report Key | 223703 |
| Report Source | 06 |
| Date Received | 1999-05-16 |
| Date of Report | 1999-05-13 |
| Date Mfgr Received | 1999-05-11 |
| 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 | CONE TIP URETERAL CATHETER |
| Generic Name | URETERAL CATHETER |
| Product Code | FGF |
| Date Received | 1999-05-16 |
| Model Number | NA |
| Catalog Number | 334108 |
| Lot Number | 86914 |
| 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 | 216945 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US |
| Baseline Brand Name | CONE TIP URETERAL 8FR |
| Baseline Generic Name | URETERAL CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 334108 |
| 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 | 1999-05-16 |