MAUDE Adverse Event Report: TRIDIEN MEDICAL 90043086 JACKSON TABLE KIT; HEAD POSITIONER

Model Number 31151010

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Burning Sensation (2146)

Event Date 12/15/2014

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a head positioner.The customer reports that a patient had redness, burning, and blistering after use of the soft touch head positioner.The customer stated the patient was prescribed silvadene cream.

Manufacturer Narrative

(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Please see the below investigation summary: a review of the device history record (dhr) was not performed during this investigation as the lot number was not received with the complaint.Device history records are reviewed and approved by quality prior to release of product.No samples were received for further evaluation; the customer reported that the samples were discarded.The most likely root cause is patient skin sensitization to the foam product.It should be noted that a biocompatibility study, (b)(4), was performed for this product code with no skin tissue response at any time during the study period.Because the issue was not found to be attributable to a manufacturing issue, no corrective or preventive actions will be taken at this time.If additional information is received the investigation will resume as needed.This complaint will be used for trending purposes.

• Brand Name: 90043086 JACKSON TABLE KIT
• Type of Device: HEAD POSITIONER
• Manufacturer (Section D): TRIDIEN MEDICAL; 1691 north delilah street; corona CA 92879
• Manufacturer (Section G): TRIDIEN MEDICAL; 1691 north delilah street; corona CA 92879
• Manufacturer Contact: janice nevius ; 15 hampshire street; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 4384266
• MDR Text Key: 5365039
• Report Number: 1282497-2015-00002
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2015

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
• Device Operator: Health Professional
• Device Model Number: 31151010
• Device Catalogue Number: 31151010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2015
• Initial Date FDA Received: 01/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other