MAUDE Adverse Event Report: DJO, LLC DONJOY; COLD PAD, SHOULDER, LOOP, NS

Model Number	11-1334-9-00000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	12/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
Complaint received that alleges "developed a rash on her arm from wetness she felt coming from the pad.Experienced itching redness and discolorization on her skin.She says that she had a towel between the pad and skin.Went to er received benadril and anti-biotics".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.

• Brand Name: DONJOY
• Common Device Name: COLD PAD, SHOULDER, LOOP, NS
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 6264316
• Report Number: 9616086-2017-00001
• Device Sequence Number: 16155781
• Product Code: ILO
• UDI-Device Identifier: 00888912005654
• UDI-Public: 00888912005654
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2017

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: Lay User/Patient
• Device Model Number: 11-1334-9-00000
• 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: 01/19/2017
• 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: Required Intervention