ARC INSTA TEMP UNK

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5085634
MDR Report Key8491731
Date Received2019-04-05
Date of Event2019-02-08
Date Added to Maude2019-04-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameARC INSTA TEMP
Generic NameTHERMOMETER, ELECTRONIC, CLINICAL
Product CodeFLL
Date Received2019-04-05
Model NumberUNK
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerARC DEVICES USA, INC.

Device Sequence Number: 1

Brand NameARC INSTA TEMP
Generic NameTHERMOMETER, ELECTRONIC, CLINICAL
Product CodeFLL
Date Received2019-04-05
Model NumberUNK
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerARC DEVICES USA, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-05

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