MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-10-12 for BLAKEMORE TUBE 2300-21 manufactured by Rusch, Inc..
[17430366]
Tube opened for use on above pt. Both balloons torn. Tube not previously used. Just taken out of package. Expiration date: "use by 1/97". Sterile eto. -1/92.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 27127 |
MDR Report Key | 27127 |
Date Received | 1995-10-12 |
Date of Report | 1995-09-13 |
Date of Event | 1995-09-13 |
Date Facility Aware | 1995-09-13 |
Report Date | 1995-09-13 |
Date Reported to FDA | 1995-09-13 |
Date Reported to Mfgr | 1995-09-13 |
Date Added to Maude | 1995-10-18 |
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 |
Reporter Occupation | RISK MANAGER |
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 | TUBE |
Product Code | FEF |
Date Received | 1995-10-12 |
Catalog Number | 2300-21 |
Lot Number | R 314313 |
Device Expiration Date | 1997-01-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | 36 MO |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 27966 |
Manufacturer | RUSCH, INC. |
Manufacturer Address | 2450 MEADOWBROOK PKWY DULUTH GA 30136 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1995-10-12 |