MAUDE Adverse Event Report: DE COMFORT, A DJO, LLC COMPANT DR COMFORT; MERRY JANE LYCRA 8 MED

Model Number 4415-M-08.0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 04/11/2017

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "patient was experiencing a ulcer on her left ankle and pain in her left foot from the shoe rubbing.Patient experienced drainage from the wound".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.

• Brand Name: DR COMFORT
• Type of Device: MERRY JANE LYCRA 8 MED
• Manufacturer (Section D): DE COMFORT, A DJO, LLC COMPANT; 10300 enterprise drive; mequon WI 53092
• Manufacturer (Section G): DR COMFORT, A DJO, LLC COMPANY; 10300 enterprise drive; mequon WI 53092
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663
• MDR Report Key: 6518617
• MDR Text Key: 73604105
• Report Number: 3008579854-2017-00001
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4415-M-08.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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