MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-01 for GERATHERM UNK manufactured by Rg Enterprises, Inc..
[16760711]
Thermometer reading is always between 0. 5 and 0. 9 degrees f less than the actual temperature. Device was being used as a basal thermometer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018770 |
| MDR Report Key | 275913 |
| Date Received | 2000-05-01 |
| Date of Report | 2000-05-01 |
| Date of Event | 2000-04-28 |
| Date Added to Maude | 2000-05-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GERATHERM |
| Generic Name | MERCURY FREE THERMOMETER |
| Product Code | FLK |
| Date Received | 2000-05-01 |
| Returned To Mfg | 2000-05-01 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | BARCODE 614801200301 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 267060 |
| Manufacturer | RG ENTERPRISES, INC. |
| Manufacturer Address | 2000 TOWN CENTER STE 1900 SOUTHFIELD MI 48075 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-05-01 |