MAUDE Adverse Event Report: DJO, LLC DONJOY; COOL, X-ACT ROM, POST-OP

Model Number 11-2151-9

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Loss of Range of Motion (2032); Complaint, Ill-Defined (2331)

Event Date 12/28/2014

Event Type  Injury  

Event Description

Complaint received from clinician that alleges "patient hit her braces together resulting in the locked hinges unlocking and the patient buckled to the ground"."office visit notes" were received from clinician and/or patient.Patient unable to do straight leg raise that she was previously capable of doing, suspicion of partial reinjury to lateral aspect of right quadriceps tendon.Device not returned to manufacturer for evaluation.

• Brand Name: DONJOY
• Type of Device: COOL, X-ACT ROM, POST-OP
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana b.c. 2224 4; MX 22244
• Manufacturer Contact: 1430 decision street; vista, CA 92081 ; 7607271280
• MDR Report Key: 4454276
• MDR Text Key: 5425895
• Report Number: 9616086-2015-00002
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-2151-9
• Device Catalogue Number: 11-2151-9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2015
• 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
• Patient Age: 57 YR