MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-04 for GERMATHERM manufactured by R.g. Medical Diagnostics.
[32981575]
Reporter states that, she placed a thermometer in her child's mouth and the tip broke inside his mouth. However, she was able to retrieve the broken piece by asking the child to spit it out. She is concerned with the material integrity of the product (thermometer).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058368 |
| MDR Report Key | 5274062 |
| Date Received | 2015-12-04 |
| Date of Report | 2015-12-04 |
| Date of Event | 2015-11-29 |
| Date Added to Maude | 2015-12-08 |
| 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 | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | GERMATHERM |
| Generic Name | THERMOMETER |
| Product Code | FLK |
| Date Received | 2015-12-04 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | R.G. MEDICAL DIAGNOSTICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-04 |