MAUDE Adverse Event Report: CINCINNATI SUB-ZERO CT-99 (COLD THERAPY PAD); PACK, HOT OR COLD, WATER CIRCULATING

Model Number 50137

Device Problems Leak/Splash (1354); Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The ct-99 is intended to provide a patient with local cold therapy by circulating chilled water through a pad that has been positioned on the patient.Pads leaked on the knees of patient.No further details were provided by complainant.No post-op infection has been reported at this time.

• Brand Name: CT-99 (COLD THERAPY PAD)
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): CINCINNATI SUB-ZERO; 12011 mosteller rd.; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller rd.; cincinnati, OH 45241
• MDR Report Key: 4404696
• MDR Text Key: 5367672
• Report Number: 1516825-2014-00004
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50137
• Device Lot Number: 13311
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other