MAUDE Adverse Event Report: DJO, LLC DONJOY; OA NANO, LATERAL, LT, M

Model Number 11-1217-3

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

Patient Problem Laceration(s) (1946)

Event Date 06/22/2017

Event Type  Injury  

Event Description

Complaint received that alleges "as he started to walk he took four steps and the caps caught up and locked up and hinges also locked up on him and fell.He was also helping a friend pick up a beer keg and his friend slowed down he took a step and again they locked he fell down and hit his head the beer keg landed on his finger he was applied with stitches.He is also limited on caring stuff".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: DONJOY
• Type of Device: OA NANO, LATERAL, LT, M
• 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, 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663
• MDR Report Key: 6741593
• MDR Text Key: 80956541
• Report Number: 9616086-2017-00012
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017

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: Lay User/Patient
• Device Model Number: 11-1217-3
• 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: 07/25/2017
• 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
• Treatment: 11-1216-3, OA NANO, LATERAL, RT, M
• Patient Outcome(s): Other