MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-08 for THE FEVER READER manufactured by Apothecary Products, Inc..
[13242]
Co has set up an fda file on this matter but without sufficient info co is unable to evaluate whether co needs to report this complaint or not. Co has had no other complaints and all inventory checked was correct and in good working order. Data missing is: 1. The lot number on the back of the strip which aloows co to match against the retained sample. 2. How the operator used the strip and if instructions on proper usage followed. With the above info, co can certainly be more responsive to the reporter's needs and concerns.
Patient Sequence No: 1, Text Type: D, B5
[20155568]
As you can see, the report contains no real data so we are unable to offer any real direction. There is no indication on how long the fever reader was left in position on the infant's forehead nor does it even tell us whether it was placed right side up. In addition, it does not tell us whether the fever reader was clean from previous usage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005363 |
| MDR Report Key | 20174 |
| Date Received | 1995-03-08 |
| Date of Report | 1995-03-07 |
| Date Added to Maude | 1995-03-09 |
| 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 |
| 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 | THE FEVER READER |
| Generic Name | STRIP FOR TAKING TEMPERATURE |
| Product Code | KPD |
| Date Received | 1995-03-08 |
| ID Number | C-30 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 20061 |
| Manufacturer | APOTHECARY PRODUCTS, INC. |
| Manufacturer Address | BURNSVILLE MN 553371248 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-03-08 |