MAUDE Adverse Event Report: DR COMFORT, A DJO LLC COMPANY DR COMFORT; TOE FILLER

Model Number L-5000

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 08/31/2015

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "toes dont fit in the space & the filler gave him an ulcer w./ foot on orthotic the big toe hangs off medially med less filler laterally.There is blood on the orthotic device where excess pressure was applied causing an ulcer to occur".Questionnaire was not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: DR COMFORT
• Type of Device: TOE FILLER
• Manufacturer (Section D): DR COMFORT, A DJO LLC COMPANY; 10300 enterprise drive; mequon WI 53092
• Manufacturer (Section G): DR COMFORT; 10300 enterprise drive; mequon WI 53092
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5180336
• MDR Text Key: 29351000
• Report Number: 3010811527-2015-00002
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: L-5000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention