MAUDE Adverse Event Report: DJO, LLC DONJOY; FULLFORCE,CI,STD,CALF,LT,L

Model Number 11-0265-4

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

Patient Problem Impaired Healing (2378)

Event Date 09/26/2014

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "the patient undergone surgery for tibial tuberosity avulsion fracture and has been prescribed a fullforce brace to stabilized and stopped knee movement for recovery.The patient was not injured through our brace but was not "cured".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.No indication event caused or contributed to serious injury, permanent impairment or death.No indication device caused or contributed to the event.

• Brand Name: DONJOY
• Type of Device: FULLFORCE,CI,STD,CALF,LT,L
• 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; tijuana, mexico 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 6004172
• MDR Text Key: 56598637
• Report Number: 9616086-2016-00025
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2016

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: Lay User/Patient
• Device Model Number: 11-0265-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/06/2016
• 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