MAUDE Adverse Event Report: DJO, LLC VENAFLOW; VENAFLOW ELITE CALF CUFF

Model Number	3040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	05/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not returned.
Event or Problem Description
Complaint received that alleges "patient developed grade 3 ulcer on lower ankle/foot.Possibly caused by the tubing on the cuff ".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: VENAFLOW
• Common Device Name: VENAFLOW ELITE CALF CUFF
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 5673697
• Report Number: 2020737-2016-00004
• Device Sequence Number: 13478470
• Product Code: JOW
• UDI-Device Identifier: 00888912022408
• UDI-Public: 00888912022408
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2016

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
• Operator of Device: Health Professional
• Device Model Number: 3040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other