MAUDE Adverse Event Report: NATUS MANUFACTURING LIMITED BOJECT; ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH

Model Number	9013S0422
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure to inject botulinum toxin in the right medial hamstring the needle broke requiring surgical intervention to retrieve the needle.

• Brand Name: BOJECT
• Common Device Name: ELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED; 5955 pacific center boulevard; san diego CA 92121
• MDR Report Key: 8154542
• Report Number: 8154542
• Device Sequence Number: 11134701
• Product Code: IKT
• UDI-Device Identifier: 00382830042420
• UDI-Public: (01)00382830042420
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2018
• Report Date (Section F): 12/06/2018

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
• Operator of Device: Other
• Device Model Number: 9013S0422
• Device Catalogue Number: 9013SO422
• Device Lot Number: 1803LL04
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 12/06/2018