MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-04 for RUSCH 2330-16 manufactured by Rusch.
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When cantor was removed from the patient, the pouch and mercury were not attached to the end of the tubeinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. There was not multiple patient involvement. 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1316 |
| MDR Report Key | 1316 |
| Date Received | 1992-09-04 |
| Date of Report | 1992-08-24 |
| Date of Event | 1992-08-07 |
| Date Facility Aware | 1992-08-07 |
| Report Date | 1992-08-24 |
| Date Reported to FDA | 1992-08-24 |
| Date Reported to Mfgr | 1992-08-10 |
| Date Added to Maude | 1992-09-22 |
| 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 | RUSCH |
| Generic Name | CANTOR TUBE 14FR |
| Product Code | FEF |
| Date Received | 1992-09-04 |
| Model Number | 2330-16 |
| Catalog Number | 2330-16 |
| Lot Number | 321518 |
| ID Number | 14FR |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 1260 |
| Manufacturer | RUSCH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-09-04 |