MAUDE Adverse Event Report: DJO, LLC DONJOY; MAXTRAX ANKLE ROM WALKER,M

Model Number 11-1385-3-00000

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

Patient Problem Tissue Damage (2104)

Event Date 04/26/2018

Event Type  Injury  

Event Description

Complaint received that alleges allergic reaction and blisters after 1 day.Hemorrhagic and oozing blisters.

• Brand Name: DONJOY
• Type of Device: MAXTRAX ANKLE ROM WALKER,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 ; 7607343126
• MDR Report Key: 7480213
• MDR Text Key: 107131299
• Report Number: 9616086-2018-00010
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-1385-3-00000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other