MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-09-15 for SENGSTAKEN TUBES 2300-21 manufactured by Rusch Mfg. Uk, Ltd..
[115716]
Pt was admitted with bleeding in the esophagus. The healthcare professional attempted to use three blakemore tubes unsuccessfully. The balloons on all three devices popped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010092-1998-00057 |
| MDR Report Key | 188395 |
| Report Source | 05,06 |
| Date Received | 1998-09-15 |
| Date of Event | 1998-08-29 |
| Date Added to Maude | 1998-09-24 |
| 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 | SENGSTAKEN TUBES |
| Generic Name | ULTRA BLAKEMORE TUBE - 3 LUMEN |
| Product Code | FEF |
| Date Received | 1998-09-15 |
| Model Number | NA |
| Catalog Number | 2300-21 |
| Lot Number | E343601 |
| ID Number | NA |
| Device Expiration Date | 2000-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 183088 |
| Manufacturer | RUSCH MFG. UK, LTD. |
| Manufacturer Address | PORTADOWN RD., LURGAN. CO. ARMAGH EI BT66 8RD |
| Baseline Brand Name | SSENGSTAKEN TUBES |
| Baseline Generic Name | ULTRA BLAKEMORE TUBE - 3 LUMEN |
| Baseline Model No | NA |
| Baseline Catalog No | 2300-21 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-09-15 |