MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. 5 POUND TRACTION SHOT WEIGHT; APPARATUS, TRACTION, NON-POWERED

Model Number 351

Device Problems Device Markings/Labelling Problem (2911); Electromagnetic Compatibility Problem (2927); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 06/02/2021

Event Type  malfunction  

Event Description

Bag, thought to be sand by staff, made it into the magnetic resonance imaging (mri) scanner with patient.Mri magnet had to quenched to get patient out of mri, could have caused harm to patient and staff.It did cause pain to patient but no harm.The tag on the bag identifying the internal material as metallic and not safe for mri is completely inadequate.

• Brand Name: 5 POUND TRACTION SHOT WEIGHT
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587
• MDR Report Key: 13366046
• MDR Text Key: 284536023
• Report Number: 13366046
• Device Sequence Number: 1
• Product Code: HST
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2022,11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 351
• Device Catalogue Number: 351
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2022
• Date Report to Manufacturer: 01/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male
• Patient Weight: 146 KG
• Patient Race: White