MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-30 for ARC DEVICES LTD INSTATEMP THERMOMETER OF TOMORROW manufactured by Arc Devices Usa, Inc..
[143584466]
The original batteries (brand is (b)(6)) exploded inside of the thermometer, causing it to fly apart with contents (lye) all over the inside of the medicine cabinet. All medications inside were penetrated with the sodium hydroxide and hydrochloric acid and had to be thrown out. This is a danger to children. I've seen many other reports on (b)(6) consumer comments. This could have exploded on a child's nightstand or when their temperature is being taken. Thermometer exploded. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086283 |
| MDR Report Key | 8565790 |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-28 |
| Date of Event | 2019-04-23 |
| Date Added to Maude | 2019-04-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | ARC DEVICES LTD INSTATEMP THERMOMETER OF TOMORROW |
| Generic Name | THERMOMETER, ELECTRONIC, CLINICAL |
| Product Code | FLL |
| Date Received | 2019-04-30 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARC DEVICES USA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-30 |