MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-26 for TEMPA DOT SINGLE USE CLINICAL THERMOMETER 5122 manufactured by 3m Healthcare.
[52413]
Donor complains of bad taste with use. Thermometers showed blue smeared dot grid when removed. It appears that plastic laminate is leaking. Co to investigate if other complaints received on this lot or investigate possible mishandling in shipping or storage. Two incidents reported. User facility is unsure of unreported incidences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011039 |
| MDR Report Key | 78685 |
| Date Received | 1997-03-26 |
| Date Added to Maude | 1997-03-28 |
| 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 | RISK MANAGER |
| 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 | TEMPA DOT SINGLE USE CLINICAL THERMOMETER |
| Generic Name | SINGLE USE CLINICAL THERMOMETER |
| Product Code | FQZ |
| Date Received | 1997-03-26 |
| Model Number | NA |
| Catalog Number | 5122 |
| Lot Number | 3F476E |
| ID Number | * |
| Device Expiration Date | 1998-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 78307 |
| Manufacturer | 3M HEALTHCARE |
| Manufacturer Address | 3M CENTER ST PAUL MN 551441000 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-26 |