MAUDE Adverse Event Report: DR COMFORT, A DJO LLC COMPANY DR. COMFORT; LINDSEY WHITE SHOE

Model Number 2040-X-07.5

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Date 08/18/2013

Event Type  Injury  

Event Description

Complaint received via summons that alleges "shoes caused ulceration, wounds, and/or infection on rt foot and toes.As a direct and proximate result of defendants' negligence and ineffective design, manufacture, distribution, alteration, or modification of the shoes and inserts, mrs (b)(6) right foot had been damaged to the point that she was hospitalized on (b)(6) 2013 with a limb threatening osteomyelitis, gas gangrene, and infection of her right foot, necessitating extensive and substantial medical treatment, surgeries, and the partial amputation of her right foot." questionnaire was not received from clinician and/or patient.Device not returned to manufacturer for evaluation.See scanned page.

• Brand Name: DR. COMFORT
• Type of Device: LINDSEY WHITE SHOE
• Manufacturer (Section D): DR COMFORT, A DJO LLC COMPANY; 10300 enterprise derive; mequon WI 53092
• Manufacturer (Section G): SHINY GROUP INTL, LLC; west south road, chang keng; liao bu town; don guan city, cn-44 52340 0; CH 523400
• Manufacturer Contact: william fisher ; 10300 enterprise drive; mequon, WI 53092 ; 2622368478
• MDR Report Key: 5292479
• MDR Text Key: 33475423
• Report Number: 3008579854-2015-00002
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2040-X-07.5
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability