MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-11-29 for ORAL THERMOMETER manufactured by Ponds (india) Ltd..
[21383880]
Customers alleged that when she placed the thermometer under her tongue, the metal tip broke off. She did not swallow any glass and immediately washed out her mouth. She also reported that she incurred no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1933255-1995-00007 |
| MDR Report Key | 28775 |
| Date Received | 1995-11-29 |
| Date of Report | 1995-11-17 |
| Date of Event | 1995-10-26 |
| Date Facility Aware | 1995-11-06 |
| Report Date | 1995-11-17 |
| Date Reported to FDA | 1995-11-17 |
| Date Reported to Mfgr | 1995-11-17 |
| Date Added to Maude | 1995-12-19 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORAL THERMOMETER |
| Generic Name | ORAL THERMOMETER |
| Product Code | FLK |
| Date Received | 1995-11-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29736 |
| Manufacturer | PONDS (INDIA) LTD. |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-11-29 |