MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-01-17 for RUSCH 264030 manufactured by Rusch Sdn. Bhd..
[254849]
The customer reports that the balloon busted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2002-00012 |
| MDR Report Key | 372940 |
| Report Source | 06 |
| Date Received | 2002-01-17 |
| Date of Report | 2002-01-16 |
| Date Mfgr Received | 2002-01-15 |
| Date Added to Maude | 2002-01-25 |
| 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 |
| Manufacturer Contact | DONNA MCLEOD |
| Manufacturer Street | 2450 MEADOWBROOK PARKWAY |
| Manufacturer City | DULUTH GA 30096 |
| Manufacturer Country | US |
| Manufacturer Postal | 30096 |
| Manufacturer Phone | 7706230816 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH |
| Generic Name | ST. BARTHOLOMEW CATHETER |
| Product Code | GBT |
| Date Received | 2002-01-17 |
| Model Number | NA |
| Catalog Number | 264030 |
| Lot Number | 97NSI1 |
| 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 | 362046 |
| Manufacturer | RUSCH SDN. BHD. |
| Manufacturer Address | P.O. BOX 28 KAMUNTING INDUSTRIAL ESTATE PERAK MY 34600 |
| Baseline Brand Name | ST BARTHOLOMEW CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 264030 |
| Baseline ID | NA |
| Baseline Device Family | UROLOGY |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K841036 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-01-17 |