MAUDE Adverse Event Report: DJO, LLC PROCARE; MAXTRAX ROM WALKER,

Model Number 79-95335

Device Problems Bent (1059); Component Missing (2306); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Not returned for review.

Event Description

Per 21cfr part 803, an mdr reportable event.Complaint received via medwatch (mw5057727) that alleges "male admitted on (b)(6) 2015 secondary 2 degree to delirium.On (b)(6) 2015 staff noted concern on l medial malleolus.Woc aprn assessed and found stage ii hapu likely due to cam boot.Pt admitted with cam boot.On (b)(6) 2015, hapu progressed to stage iii due to infection of wound.Cam boot discontinued.Event abated after use stopped or dose reduced; yes.Diagnosis or reason for use: diabetic foot w/poa wound".Questionnaire was not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

Manufacturer Narrative

Product was returned for review.Item is not very used, side bars are not aligned one to another, do not match, one is bent a side, also is missing a locking key pin on right side dorsi flexion adjustment unit.Side bars, these are little stiff to move back and forward, not aligned, velcro's are good.Possible adjustment problems.

• Brand Name: PROCARE
• Type of Device: MAXTRAX ROM WALKER,
• 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: 5265397
• MDR Text Key: 32663294
• Report Number: 9616086-2015-00031
• Device Sequence Number: 1
• Product Code: IPG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 79-95335
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention