MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-26 for BLAKEMORE TUBE manufactured by Johnson And Johnson Professional, Inc..
[20180]
Rptr complains of communication between esophageal and gastric parts. Tube possibly faulty. When air or saline is injected into one port the other balloon port, the other balloon would inflate. Balloons should be independent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007994 |
| MDR Report Key | 29070 |
| Date Received | 1995-12-26 |
| Date of Report | 1995-12-20 |
| Date of Event | 1995-09-25 |
| Date Added to Maude | 1995-12-28 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLAKEMORE TUBE |
| Generic Name | TUBE, DECOMPRESSION |
| Product Code | FEF |
| Date Received | 1995-12-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30070 |
| Manufacturer | JOHNSON AND JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-12-26 |