NOVAPLUS INSTANT HOT PACK V11443-012B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for NOVAPLUS INSTANT HOT PACK V11443-012B manufactured by Cardinal Health.

Event Text Entries

[180852738] Add'l info received from reporter on 02/20/2020. "hot pack ruptured when staff member attempted to activate by squeezing. The content caused redness and mild irritation to staff member's arm. A second hot pack ruptured during the same shift involving a different staff member. No harm to pt. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093179
MDR Report Key9739732
Date Received2020-02-20
Date of Report2020-02-07
Date of Event2020-02-05
Date Added to Maude2020-02-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOVAPLUS INSTANT HOT PACK
Generic NamePACK, HOT OR COLD, DISPOSABLE
Product CodeIMD
Date Received2020-02-20
Catalog NumberV11443-012B
Lot NumberV9S079
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH
Manufacturer AddressDUBLIN OH 43017 US 43017


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-20

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