MAUDE Adverse Event Report: MEDICAL MODELING, INC./3-D SYSTEMS INC. CLEARVIEW ANATOMICAL MODEL; TEMPLATE, ANATOMICAL MODEL

Model Number CLEARVIEW

Device Problems Fail-Safe Design Failure (1222); Physical Property Issue (3008); Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/27/2015

Event Type  Injury  

Event Description

The company's indications for use recommends the use of steam sterilization only.Steam sterilization, when used, destroys the physical structure of the model as well as the color indicators.

• Brand Name: CLEARVIEW ANATOMICAL MODEL
• Type of Device: TEMPLATE, ANATOMICAL MODEL
• Manufacturer (Section D): MEDICAL MODELING, INC./3-D SYSTEMS INC.; 17301 west colfax ave., suite 300; golden CO 80401
• MDR Report Key: 5480639
• MDR Text Key: 39686798
• Report Number: 5480639
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: CLEARVIEW
• Device Catalogue Number: CLEARVIEW
• Device Lot Number: 57006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES