MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, LLC COLD THERAPY; COLD THERAPY PAD

Model Number CT-99

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

User reported a ct-99 pad leaked on a patient's surgical site.Csz opened complaint (b)(4).

Event Description

Customer stated a ct-99 pad leaked on a patient's surgical site.

Manufacturer Narrative

Investigation determined that the machining die detail was damaged.The die was repaired to correct.

• Brand Name: COLD THERAPY
• Type of Device: COLD THERAPY PAD
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, LLC; 12011 mosteller road; cincinnati OH 45241
• Manufacturer (Section G): CINCINNATI SUB-ZERO PRODUCTS, LLC; 12011 mosteller road; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller road; cincinnati, OH 45241 ; 5133265295
• MDR Report Key: 8171347
• MDR Text Key: 130627953
• Report Number: 1516825-2018-00022
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CT-99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1