MAUDE Adverse Event Report: DJO, LLC DONJOY; ICEMAN, W/COLDPAD, SHOULDER, LOOP, NS

Model Number 11-9098

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Complaint received that alleges "surgical room placed the iceman classic donjoy with the shoulder wrap pad, and surgeon indicated that she should not remove it until she saw the doctor.On (b)(6) cx saw the doctor and everything was fine.Doctor wanted them to keep everything how is was.On (b)(6) patient started to feel a discomfort and when they look it was just a small rash, on (b)(6) patient had blisters all over her left breast, and her back and they had puss.Did not continue to use product.On (b)(6) doctor told patient not to put on the item since she had burns".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.No indication event caused or contributed to permanent impairment or death.

• Brand Name: DONJOY
• Type of Device: ICEMAN, W/COLDPAD, SHOULDER, LOOP, NS
• 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: 5511585
• MDR Text Key: 40725652
• Report Number: 9616086-2016-00009
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-9098
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other