COLD THERAPY CT-99

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-17 for COLD THERAPY CT-99 manufactured by Cincinnati Sub-zero Products, Llc.

Event Text Entries

[130627953] User reported a ct-99 pad leaked on a patient's surgical site. Csz opened complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[130627954] Customer stated a ct-99 pad leaked on a patient's surgical site.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1516825-2018-00022
MDR Report Key8171347
Report SourceHEALTH PROFESSIONAL
Date Received2018-12-17
Date of Report2018-12-12
Date Mfgr Received2018-11-21
Date Added to Maude2018-12-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA MIRACLE
Manufacturer Street12011 MOSTELLER ROAD
Manufacturer CityCINCINNATI OH 45241
Manufacturer CountryUS
Manufacturer Postal45241
Manufacturer Phone5133265295
Manufacturer G1CINCINNATI SUB-ZERO PRODUCTS, LLC
Manufacturer Street12011 MOSTELLER ROAD
Manufacturer CityCINCINNATI OH 45241
Manufacturer CountryUS
Manufacturer Postal Code45241
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOLD THERAPY
Generic NameCOLD THERAPY PAD
Product CodeILO
Date Received2018-12-17
Model NumberCT-99
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCINCINNATI SUB-ZERO PRODUCTS, LLC
Manufacturer Address12011 MOSTELLER ROAD CINCINNATI OH 45241 US 45241


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-17

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