MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MEDI-THERM; SYSTEM, THERMAL REGULATING

Catalog Number MTA7900

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 10/20/2016

Event Type  malfunction  

Event Description

It was reported that a patient received blisters while using the temperature therapy device.

Manufacturer Narrative

Further information regarding the alleged event was unable to be obtained and the device was not returned for evaluation.

Event Description

It was reported that a patient received blisters while using the temperature therapy device.

• Brand Name: MEDI-THERM
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6112411
• MDR Text Key: 60754157
• Report Number: 0001831750-2016-00350
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MTA7900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1