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 |