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

Model Number 335374

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Swelling (2091)

Event Date 01/28/2019

Event Type  malfunction  

Event Description

Patient using aqua k pad developed blister to buttocks.Noted that device was set to continuous.Concern that this device can be set to continuous rather than 20-30 minute cycle.

• Brand Name: AQUA K
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 8468885
• MDR Text Key: 140492467
• Report Number: 8468885
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 335374
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2019
• Date Report to Manufacturer: 04/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18250 DA