MAUDE Adverse Event Report: TIDI PRODUCTS, LLC. ZERO GRAVITY RADIATION PROTECTION SYSTEM MONORAIL HINGED SWING ARM; APRON, LEADED

Model Number ZGM-6-5H

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

The bar inserted into the mechanism that holds the face, shoulder and body shield apparatus came out of the holder and hit the provider on the head.No injuries.Fda safety report id # (b)(4).

• Brand Name: ZERO GRAVITY RADIATION PROTECTION SYSTEM MONORAIL HINGED SWING ARM
• Type of Device: APRON, LEADED
• Manufacturer (Section D): TIDI PRODUCTS, LLC.; hannover DE 30174
• MDR Report Key: 12835185
• MDR Text Key: 281072270
• Report Number: MW5105408
• Device Sequence Number: 1
• Product Code: EAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/15/2021

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: Health Professional
• Device Model Number: ZGM-6-5H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1