MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-30 for IVAC TEMP PLUS II PROBE 2882A manufactured by Alaris Medical Systems.
[28908000]
Rectal temperature became loose and thermometer probe came loose, possibly remaining in rectum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5161530 |
| MDR Report Key | 5161530 |
| Date Received | 2004-06-30 |
| Date of Report | 2004-06-29 |
| Date of Event | 2004-06-24 |
| Date Facility Aware | 2004-06-29 |
| Date Reported to FDA | 2004-06-29 |
| Date Reported to Mfgr | 2004-06-29 |
| Date Added to Maude | 2015-10-20 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IVAC TEMP PLUS II PROBE |
| Generic Name | RECTAL PROBE |
| Product Code | EXX |
| Date Received | 2004-06-30 |
| Model Number | 2882A |
| Device Availability | Y |
| Device Age | 20 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALARIS MEDICAL SYSTEMS |
| Manufacturer Address | SAN DIEGO CA 921212733 US 921212733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-06-30 |