MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-28 for TEMP-A-AWAY KIT (ORAL) 3702 manufactured by Becton Dickinson And Compnay.
[3142]
Pct took temperature of patient. Patient bit the thermometer and incurred a small cut on his tongue. All mercury remained intact in the bulb of the thermometer. Invalid 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5529 |
| MDR Report Key | 5529 |
| Date Received | 1993-04-28 |
| Date of Event | 1993-03-28 |
| Date Facility Aware | 1993-03-28 |
| Date Reported to Mfgr | 1993-03-28 |
| Date Added to Maude | 1993-07-14 |
| 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 | TEMP-A-AWAY KIT (ORAL) |
| Product Code | KPD |
| Date Received | 1993-04-28 |
| Model Number | 3702 |
| Catalog Number | 3702 |
| ID Number | N/A |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 5221 |
| Manufacturer | BECTON DICKINSON AND COMPNAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. No Informationnvalid Deathata | 1993-04-28 |