MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-06 for CONRAY 43 manufactured by Mallinckrodt.
[1121]
Patient became extremely nauseated-contrast stoppeddevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was multiple patient involvement. Number of patients involved: 3. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated, performance tests performed. Results of evaluation: unanticipated adverse reaction - short term. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device recalled by manufacturer/distributor. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1152 |
| MDR Report Key | 1152 |
| Date Received | 1992-07-06 |
| Date of Report | 1992-06-03 |
| Date of Event | 1992-04-14 |
| Date Facility Aware | 1992-04-16 |
| Report Date | 1992-06-03 |
| Date Reported to FDA | 1992-06-03 |
| Date Reported to Mfgr | 1992-04-16 |
| Date Added to Maude | 1992-08-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONRAY 43 |
| Generic Name | MEDIUM CONTRAST RADIOLOGIC |
| Product Code | KTA |
| Date Received | 1992-07-06 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 1102 |
| Manufacturer | MALLINCKRODT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-06 |