MAUDE Adverse Event Report: DJO, LLC DONJOY; ICEMAN

Model Number 11-0494

Device Problem Fluid/Blood Leak (1250)

Patient Problem Pain (1994)

Event Date 12/12/2013

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received via legal action that alleges "donjoy cold pump which was leaking on her wounds for 6 days.Seen by (b)(6) 3 days ago and dressing changed.Had diffuse blisters on foot.No fever since.Today, increasing pain and pain in r ankle, unable to bear weight on r foot.No trauma or injury.Significant underlying chronic pain on methadone prior to procedure.Now taking dilaudid and valium in addition without relief".Questionnaire was not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: DONJOY
• Type of Device: ICEMAN
• 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: 5214988
• MDR Text Key: 30914046
• Report Number: 9616086-2015-00029
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-0494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• 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): Required Intervention