MAUDE Adverse Event Report: DJO, LLC CMF; OL1000 SINGLE COIL SIZE 1

Model Number	01-211-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint received that alleges "patient states that they used the device around five times and the device was causing the strength in the patient's hand to lessen.The patient went to their doctor and they told the patient they didn't know why they were experiencing these symptoms".Questionnaire not received from customer or clinician.Device not received manufacturer at this time.

• Brand Name: CMF
• Common Device Name: OL1000 SINGLE COIL SIZE 1
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 7404922
• Report Number: 3012446970-2018-00001
• Device Sequence Number: 19261982
• Product Code: LOF
• UDI-Device Identifier: 00888912161749
• UDI-Public: 00888912161749
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P910066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/06/2018

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: Lay User/Patient
• Device Model Number: 01-211-0001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2018
• 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