MAUDE Adverse Event Report: DJO, LLC DONJOY; DONJOY ICEMAN CLEARCUBE

Model Number 11-0493

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

Patient Problem Necrosis (1971)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Receipt of medwatch report was manufacturers first notification of this event.Medwatch event description alleges "on her first post-op visit, she was found to be experiencing a fair amount of pain and had been taking pain medication and icing regularly.She reportedly had not been using a barrier between her skin and the ice, and the provider described an ice burn on the medial and lateral aspects of her incision.She was instructed to stop using the ice therapy.The patient was referred to a plastic surgeon and has undergone a series of staged reconstructive procedures including grafts and muscle flap closure.Grafting required removal of the implant and placement of an antibiotic spacer approximately six weeks post right total knee surgery." questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: DONJOY
• Type of Device: DONJOY ICEMAN CLEARCUBE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, mexico 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5586997
• MDR Text Key: 43013737
• Report Number: 9616086-2016-00011
• Device Sequence Number: 1
• Product Code: ILO
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-0493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2016
• 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