MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE

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

Patient Problem Loss of Vision (2139)

Event Date 11/21/2013

Event Type  Injury  

Event Description

The following was reported to arjohuntleigh by the physician: on (b)(6) 2013, the patient was placed on the rotoprone.On (b)(6) 2013, it was noted that patient had developed blistering on the lower eyelid which was not attributed to rotoprone therapy.On (b)(6) 2013, the physician stated that the family alleged the rotoprone possibly caused blindness in the patient's eye.There was no additional information at the time of this report.

Manufacturer Narrative

This report is being filed by the manufacturer arjohuntleigh, inc.(b)(4).Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.(b)(4).As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.And registration # (b)(4).Additional information will be provided upon conclusion of the manufacturer investigation.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 12625 wetmore road; suite 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 12625 wetmore road; suite 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore road; suite 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 3597086
• MDR Text Key: 4090652
• Report Number: 3010048749-2014-00001
• Device Sequence Number: 1
• Product Code: IKZ
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2013
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other