MAUDE Adverse Event Report: MIZUHO OSI 5 POUND SHOT WEIGHT; TRACTION SHOT WEIGHT

Model Number	351
Medical Device Problem Codes	Inadequate or Insufficient Training (1643); Use of Device Problem (1670); Device Markings/Labelling Problem (2911); Device Unsafe to Use in Environment (2918); Device-Device Incompatibility (2919); Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had lower limb traction.Preparing to transport for mri imaging, staff disconnected the traction and laid the weight bag on the bed by his feet.Everyone assumed it was a sandbag.The facility had both sand bag weights and iron shot weights and generally didn't differentiate.The weight bag was more than ten years old and the tag indicating that it was filled with metal shot had curled so it was not readily visible.The handheld ferromagnetic scanner used on the weight bag's brass grommet did not alarm, so the bag was allowed to enter the room.As they approached the magnet, the gurney was pulled out of their hands and toward the magnet.The bag slid along the bed and up under the patient, causing pain but no worsening of the injury.Staff quenched the magnet to release it.

• Brand Name: 5 POUND SHOT WEIGHT
• Common Device Name: TRACTION SHOT WEIGHT
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern av; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern av; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 13636745
• Report Number: 2921578-2022-00002
• Device Sequence Number: 13990205
• Product Code: HST
• UDI-Device Identifier: 00842430111693
• UDI-Public: 00842430111693
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 351
• Device Catalogue Number: 351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MRI DEVICE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male