MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-30 for NOT KNOWN 763ORAL manufactured by Not Known.
[15183613]
Babe admitted to nicu. Cbc and crp obtained and returned wnl. No fever on admission. Dr. Arrived at 1600 to do lp. Began to question the validity of the temp taken at home. Dad arrives with home thermometer, and temp taken with that is 101. 7. Immediately took temp with our thermometer and that was 98. Lp cancelled. Did not start antibiotics and kept child over night and all temps wnl. Discharged to home next morning. Clinical engineering verifies the accuracy of hosp owned thermometers. Thermometer is a digital thermometer that comes in a prepackaged pack that is given to parents and babies at the time of baby's birth. Digital thermometers are not checked in the hosp prior to being given to the parents. Facility does tell mfr of the complete pack to include a thermometer. Mfr picks the thermometer to be placed in the pack. See scanned pages.
Patient Sequence No: 1, Text Type: D, B5
[15189103]
An infant admitted to nicu for sepsis workup, reportedly had a rectal temp of 103. Rectally at home using the thermometer received for home use as a newborn, at the kearney clinic baby did not have a fever, but proceeded with a blood and urinalysis. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007822 |
| MDR Report Key | 1084305 |
| Date Received | 2008-07-30 |
| Date of Report | 2008-07-30 |
| Date of Event | 2008-07-22 |
| Date Added to Maude | 2008-08-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOT KNOWN |
| Generic Name | THERMOMETER |
| Product Code | FLK |
| Date Received | 2008-07-30 |
| Model Number | 763ORAL |
| Catalog Number | 763ORAL |
| Lot Number | 12251107 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1063117 |
| Manufacturer | NOT KNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-07-30 |