MAUDE Adverse Event Report: DON JOY COLD PAD UNIVERSAL LOOP

Catalog Number 140902

Device Problem Leak/Splash (1354)

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

Event Date 03/23/2015

Event Type  malfunction  

Event Description

Pt reported leaking at the site of connection between the pad and the iceman cooler.Leakage does not occur until the unit has been running for a period of time.Dates of use: (b)(6) 2015.

• Brand Name: COLD PAD UNIVERSAL LOOP
• Type of Device: COLD PAD UNIVERSAL LOOP
• Manufacturer (Section D): DON JOY
• MDR Report Key: 4664618
• MDR Text Key: 5607364
• Report Number: MW5041878
• Device Sequence Number: 2
• Product Code: ILO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/30/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 140902
• Device Lot Number: 11-0679-9-000
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1