MAUDE Adverse Event Report: DJO, LLC DONJOY; LEGEND

Model Number 11-0453-4-06060

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

Patient Problem Peroneal Nerve Palsy (2362)

Event Date 11/08/2015

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges " after wearing this brace for 1 month, the patient had to go to the hospital between (b)(6) 2015 because of a lesion of the peroneal nerve.The hospital wrote a letter confirming that this lesion of the peroneal nerve was induced by our donjoy legend brace".Questionnaire was received from customer or clinician.Questionnaire indicates that on (b)(6) 2015, the patient suffered a "lesion of the peroneal nerve" while wearing the brace.Shape of brace, and strap length had been altered for the patient.Patient was hospitalized for injury, type of treatment unknown.Device not returned to manufacturer for evaluation.

• Brand Name: DONJOY
• Type of Device: LEGEND
• 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: 6210399
• MDR Text Key: 63477819
• Report Number: 9616086-2016-00029
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2016

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: 11-0453-4-06060
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2016
• 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): Hospitalization; Other