MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 1997-06-03 for BARIFLO 882 manufactured by Therapex.
[63171]
Customer claims the unit got very hot and then started smoking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411512-1997-00001 |
| MDR Report Key | 96180 |
| Report Source | 06,08 |
| Date Received | 1997-06-03 |
| Date of Report | 1997-06-02 |
| Date of Event | 1997-02-11 |
| Date Mfgr Received | 1997-02-12 |
| Date Added to Maude | 1997-06-06 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARIFLO |
| Generic Name | AUTOMATIC REMOTE FLOW CONTROL SYSTEM |
| Product Code | FCD |
| Date Received | 1997-06-03 |
| Model Number | NA |
| Catalog Number | 882 |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 94961 |
| Manufacturer | THERAPEX |
| Manufacturer Address | 11100 COLBERT ANJOU QUEBEC CA HIJ2N9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-03 |