MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ALTRIX, DOMESTIC; SYSTEM, THERMAL REGULATING

Catalog Number 8001000001

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 05/30/2017

Event Type  malfunction  

Event Description

It was alleged by the customer that the patient formed blisters during use of the device.

Manufacturer Narrative

This device was incorrectly reported, it was identified during the complaint investigation that this device did not cause or contribute to the alleged event.

Event Description

It was alleged by the customer that the patient formed blisters during use of the device.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was alleged by the customer that the patient formed blisters during use of the device.

• Brand Name: ALTRIX, DOMESTIC
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6673018
• MDR Text Key: 78691498
• Report Number: 0001831750-2017-00272
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152266
• 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,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2017
• 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