MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-02-24 for BLAKEMORE TUBE 230021 manufactured by Rusch Mfg. Uk, Ltd..
[122480]
It has been rpeorted that one device had a leak in the stomach balloon prior to use and another two devices developed leaks in the same place after insertion. Several telephone calls to the hosp have been made to obtain further info. No success as yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010092-1998-00005 |
| MDR Report Key | 151941 |
| Report Source | 06 |
| Date Received | 1998-02-24 |
| Date of Report | 1998-02-24 |
| Date Mfgr Received | 1998-02-20 |
| Date Added to Maude | 1998-02-27 |
| 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 | BLAKEMORE TUBE |
| Generic Name | SENGSTAKEN TUBE |
| Product Code | FEF |
| Date Received | 1998-02-24 |
| Model Number | NA |
| Catalog Number | 230021 |
| 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 | 148067 |
| Manufacturer | RUSCH MFG. UK, LTD. |
| Manufacturer Address | PORTADOWN RD., LURGAN, CO. ARMAGH, N. IRELAND UK BT66 8RD |
| Baseline Brand Name | SENGSTAKEN TUBES |
| Baseline Generic Name | ULTRA BLAKEMORE TUBE - 3 LUMEN |
| Baseline Model No | NA |
| Baseline Catalog No | 230021 |
| Baseline ID | NA |
| Baseline Device Family | ULTRA BLAKEMORE TUBE - 3 LUMEN |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K841038 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-02-24 |