MAUDE Adverse Event Report: STRYKER MEDICAL AQUA K PAD; SYSTEM, THERMAL REGULATING

Event Date 08/06/2018

Event Type  malfunction  

Event Description

Writer called room, therapy noted a wound on right upper back.Writer to bedside to assess, md notified and aware.Received orders for wound care consult.Pt stated he had previously used an aqua k pad on back.Aqua k pad found on floor, removed from room and sent to maintenance.Patient has 2 one centimeter burn wounds presumed to be from heating pad.One wound is healed and the second is being treated by wound team.

• Brand Name: AQUA K PAD
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 7868145
• MDR Text Key: 119945114
• Report Number: 7868145
• Device Sequence Number: 1
• Product Code: DWJ
• 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: 08/10/2018

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 08/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N