MAUDE Adverse Event Report: DJO, LLC AIRCAST; FOLDERS SEARCHES GLOBAL SEARCHES WORKFLOW ROUTINGS PER

Model Number 01EP-S

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Breakdown (2681)

Event Date 07/17/2017

Event Type  Injury  

Event Description

Complaint received that alleges "large wound at heel, wounded skin is softened and white with black frame, looks like after a long bath, maceration".Questionnaire was received from customer or clinician.Clinician had directed patient wear the walker 14 days without opening, lay down the foot very often, not to walk too much, wear the white sock.Device not reviewed by manufacturer at this time.

Manufacturer Narrative

Product was returned for review."minimally used, the walker is in good conditions ".

• Brand Name: AIRCAST
• Type of Device: FOLDERS SEARCHES GLOBAL SEARCHES WORKFLOW ROUTINGS PER
• 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: 6750443
• MDR Text Key: 81277580
• Report Number: 9616086-2017-00013
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

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: 01EP-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 09/06/2017
• 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): Other