MAUDE Adverse Event Report: DJO, LLC DR COMFORT; ANTIEMB 18MMHG KN CT BLACK XL/SHORT

Model Number 11300XL-SHORT

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/26/2017

Event Type  Injury  

Event Description

Complaint received that alleges "allergic reaction to the color die of the stocking and broke out in hives.Patient was in the hospital for 4 days, out of the hospital and well now".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.

Manufacturer Narrative

Product was returned for review."conditions were evaluated visually: the product doesn't present any defects".

• Brand Name: DR COMFORT
• Type of Device: ANTIEMB 18MMHG KN CT BLACK XL/SHORT
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DR COMFORT, A DJO, LLC COMPANY; 10300 enterprise drive; mequon 53092
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663
• MDR Report Key: 6731926
• MDR Text Key: 80669270
• Report Number: 3008579854-2017-00004
• Device Sequence Number: 1
• Product Code: DWL
• UDI-Device Identifier: 00888912223874
• UDI-Public: 00888912223874
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11300XL-SHORT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization