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

Model Number 11-1334-9-00000

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

Patient Problem Rash (2033)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event 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
• Type of Device: COLD PAD, 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: 6264316
• MDR Text Key: 65319834
• Report Number: 9616086-2017-00001
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00888912005654
• UDI-Public: 00888912005654
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11-1334-9-00000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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