MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-30 for BLAKEMORE TUBE 2300-21 manufactured by Rusch Intl, Inc..
[14258]
Md inserted tube into pt. While inflating balloon, balloon burst.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 28077 |
| MDR Report Key | 28077 |
| Date Received | 1995-10-30 |
| Date of Report | 1995-10-26 |
| Date of Event | 1995-10-18 |
| Date Facility Aware | 1995-10-18 |
| Date Reported to Mfgr | 1995-10-19 |
| Date Added to Maude | 1995-11-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLAKEMORE TUBE |
| Generic Name | BLAKEMORE TUBE |
| Product Code | FEF |
| Date Received | 1995-10-30 |
| Catalog Number | 2300-21 |
| Lot Number | E350701 |
| Device Expiration Date | 2000-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 28988 |
| Manufacturer | RUSCH INTL, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY DULUTH GA 30136 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-10-30 |