MAUDE Adverse Event Report: DR COMFORT, A DJO, LLC COMPANY DR COMFORT; GSA WILLIAM BLACK 13 XWIDE

Model Number 6310-X-13.0

Device Problem Mechanical Problem (1384)

Patient Problem Ulcer (2274)

Event Date 05/03/2018

Event Type  Injury  

Event Description

Complaint received that alleges "right foot beginning to ulcer with drainage by the 4th and 5th met pad".Questionnaire not received from customer or clinician.Device not received manufacturer at this time.

• Brand Name: DR COMFORT
• Type of Device: GSA WILLIAM BLACK 13 XWIDE
• Manufacturer (Section D): DR COMFORT, A DJO, LLC COMPANY; 10300 enterprise drive; mequon 53092
• Manufacturer (Section G): DR COMFORT, A DJO, LLC COMPANY; 10300 enterprise drive; mequon 53092
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663 ; 7607343126
• MDR Report Key: 7499695
• MDR Text Key: 107769973
• Report Number: 3008579854-2018-00003
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6310-X-13.0
• Device Lot Number: FY--53--16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other