MAUDE Adverse Event Report: DONJOY DONJOY COLD PAD

Model Number 11-0675-9-00000

Device Problem Break (1069)

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

Event Date 06/28/2016

Event Type  malfunction  

Event Description

Pt reported that within 24 hrs of his surgery, the seams on his donjoy cold pad / polar pack had come apart soaking his dressing.Pt returned to the ed for dressing change.No injury to the pt.

• Brand Name: DONJOY COLD PAD
• Type of Device: DONJOY COLD PAD
• Manufacturer (Section D): DONJOY; vista CA 92081
• MDR Report Key: 5771860
• MDR Text Key: 48923568
• Report Number: MW5063227
• Device Sequence Number: 1
• 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: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11-0675-9-00000
• Device Lot Number: 140225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR