MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-05 for ARC INSTA TEMP UNK manufactured by Arc Devices Usa, Inc..
[141318984]
Caller is reporting that the thermometer battery exploded; it sounded like a loud gunshot. He stated that the was not sure where the noise came from at first or what had caused the explosion but he discovered that the case of the unit was blown open the following day. The mfr was not contacted as of yet. Caller stated that he is concerned that this thermometer which can be used for children as well poses a safety hazard and should be reported. Retailer: (b)(6). Retailer state: (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085634 |
| MDR Report Key | 8491731 |
| Date Received | 2019-04-05 |
| Date of Event | 2019-02-08 |
| Date Added to Maude | 2019-04-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 INSTA TEMP |
| Generic Name | THERMOMETER, ELECTRONIC, CLINICAL |
| Product Code | FLL |
| Date Received | 2019-04-05 |
| Model Number | UNK |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ARC DEVICES USA, INC. |
| Brand Name | ARC INSTA TEMP |
| Generic Name | THERMOMETER, ELECTRONIC, CLINICAL |
| Product Code | FLL |
| Date Received | 2019-04-05 |
| Model Number | UNK |
| 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 | 2019-04-05 |