MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HEAVY DUTY TRAPEZE; PATIENT HELPER

Model Number 3095

Device Problems Detachment Of Device Component (1104); Material Separation (1562); Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2016

Event Type  malfunction  

Event Description

When the patient pulled on the trapeze, the triangle piece separated and fell onto the patient.

Manufacturer Narrative

The complaint could not be verified because a 3071 (obsoleted 3/2012) was returned instead of a 3095.The part that was returned was reassembled prior to evaluation.

Event Description

When the patient pulled on the trapeze, the triangle piece separated and fell onto the patient.

• Brand Name: HEAVY DUTY TRAPEZE
• Type of Device: PATIENT HELPER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: anne leblanc ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 5524130
• MDR Text Key: 41460782
• Report Number: 2921578-2016-00007
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3095
• Device Catalogue Number: 3095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Weight: 91