MAUDE Adverse Event Report: DEROYAL GUATEMALA DEROYAL; ORTHOSIS, LIMB BRACE

Catalog Number 1220917

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

Patient Problem Skin Irritation (2076)

Event Date 03/07/2014

Event Type  No Answer Provided  

Event Description

The hospital reported that the knee immobilizer caused skin breakdown to the patient.

Manufacturer Narrative

Deroyal: the reported device is not available for evaluation.The investigation into the root cause is in process.

• Brand Name: DEROYAL
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): DEROYAL GUATEMALA; GT
• Manufacturer Contact: courtney rinehart ; 200 debusk lane; powell, TN 37849 ; 8653622122
• MDR Report Key: 3733260
• MDR Text Key: 4271823
• Report Number: 3005225477-2014-00003
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1220917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/07/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2014
• Date Manufacturer Received: 03/07/2014
• 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