MAUDE Adverse Event Report: DJO, LLC COMPEX; COMPEX WIRELESS USA COMPLETE SET

Model Number 2540660

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/17/2016

Event Type  Injury  

Event Description

Plaintiffs counsel claims in the complaint that "electrode stimulation proved to be dangerously high, causing mr.(b)(6)'s bicep to forcefully and unnaturally contract to a dangerous degree and proceeded to injure our client.Impression: rotator cuff tendinosis with mild intrasubstance partial tearing.There is no full thickness tear present.Mild subacromial and subdeltoid bursitis.There is a complete tear of the biceps tendon with the proximal portion of the biceps extending anteriorly and superior to the subscapularis muscle bundle.Superior labral tearing.Glenohumeral joint effusion.Acromioclavicular joint hypertrophy and inflammation".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: COMPEX
• Type of Device: COMPEX WIRELESS USA COMPLETE SET
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663
• MDR Report Key: 6697220
• MDR Text Key: 79571524
• Report Number: 9616086-2017-00011
• Device Sequence Number: 1
• Product Code: NGX
• UDI-Device Identifier: 00888912290463
• UDI-Public: 00888912290463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 07/10/2017

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
• Device Operator: Other
• Device Model Number: 2540660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other