MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-05-01 for FEVER THERMOMETER COMPONENT OF NURSERY CARE KIT 430 COMPONENT OF #420 SAME manufactured by Safety 1st, Inc..
[61222]
End of glass thermometer broke off in baby's rectum.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1223794-1997-00001 |
| MDR Report Key | 89464 |
| Report Source | 00 |
| Date Received | 1997-05-01 |
| Date of Report | 1997-04-29 |
| Date Mfgr Received | 1997-04-25 |
| Date Added to Maude | 1997-05-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | ATTORNEY |
| 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 | 3 |
| Brand Name | FEVER THERMOMETER COMPONENT OF NURSERY CARE KIT |
| Generic Name | MERCURY-IN-GLASS THERMOMETER |
| Product Code | FLK |
| Date Received | 1997-05-01 |
| Model Number | 430 COMPONENT OF #420 |
| Catalog Number | SAME |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 88445 |
| Manufacturer | SAFETY 1ST, INC. |
| Manufacturer Address | 210 BOYLSTON STREET CHESTNUT HILL MA 02167 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-01 |