MAUDE Adverse Event Report: DJO, LLC DONJOY; PACK, HOT OR COLD, WATER CIRCULATING

Model Number 11-0679-9-00000

Device Problem Leak/Splash (1354)

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

Event Date 10/04/2019

Event Type  malfunction  

Event Description

Patient found to have a wet ace wrap from the cold therapy pad.Unsure where the pad was leaking water.Pad removed, ace wrap reapplied.Dressing underneath ace wrap was dry and intact.

• Brand Name: DONJOY
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): DJO, LLC; 1430 decision st; vista CA 92081
• MDR Report Key: 9218292
• MDR Text Key: 163190414
• Report Number: 9218292
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00888912003629
• UDI-Public: (01)00888912003629
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11-0679-9-00000
• Device Lot Number: 141908
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26280 DA