MAUDE Adverse Event Report: TIDI PRODUCTS LLC C-ARMOR

Catalog Number CFB5523

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 04/25/2018

Event Type  malfunction  

Event Description

Hair found in c-arm drape while opening for a case.

• Brand Name: C-ARMOR
• Type of Device: C-ARMOR
• Manufacturer (Section D): TIDI PRODUCTS LLC
• MDR Report Key: 7472290
• MDR Text Key: 107069020
• Report Number: MW5076853
• Device Sequence Number: 1
• Product Code: KKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CFB5523
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1