MAUDE Adverse Event Report: DJO, LLC CMF OL1000 DUAL COIL; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number	01-203-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	06/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Event or Problem Description
It was reported that the patient "had an adverse reaction to the cmf ol1000." patient's orthopedic doctor prescribed this unit for a non-union fibula-ankle break.Patient used it for six, 30-minute treatments.After the fifth & sixth treatments, her ankle became incredibly constricted and numb.The numbness has also involved the bottom & top of her foot, calf, and thigh.Patient discontinued usage immediately & informed her doctor.The constriction/numbness has reportedly not dissipated.Patient can barely walk due to the numbness.
Additional Manufacturer Narrative
H3, h6: production records of ol1000 dual coil part number: 01-203-0001, serial number: (b)(6) were reviewed.The device fully passed testing prior to release.One ol1000 dual coil (part number: 01-203-0001, serial number: (b)(6) was returned for evaluation.The product met specifications and did not malfunction.A full treatment was ran at the test station.Observed results were within specification.The device performed as expected.The reported event could not be duplicated.No failure was identified.

• Brand Name: CMF OL1000 DUAL COIL
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8809318
• Report Number: 3012446970-2019-00023
• Device Sequence Number: 320059
• Product Code: LOF
• UDI-Device Identifier: 00888912011488
• UDI-Public: 00888912011488
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P910066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 01-203-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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: Required Intervention