MAUDE Adverse Event Report: OSSUR MIAMI J COLLAR; ORTHOSIS, CERVICAL

Model Number MJ-400

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pressure Sores (2326)

Event Date 08/21/2015

Event Type  Injury  

Event Description

An elderly female was brought to the emergency department following a traumatic motor vehicle accident.She was immediately assessed, including placement of a miami j collar, and taken for orthopedic surgery due to significant blood loss from an open fracture of her right lower extremity.The patient was on strict bed rest with log-rolling only for several days until she was ordered to lie flat with no log rolling.She was fitted for a new miami j collar.A week later, she underwent spinal fusion.A few days later, the patients activity level was ordered for progressive ambulation and the patient was transferred.She required 2-3 staff to assist for turning.Two months after the motor vehicle accident, an unstageable pressure ulcer was noted on the patient's right occipital area at the edge of where the miami j collar rests.A few days later a second unstageable pressure ulcer was noted on the patient's left occipital area also believed to be related to the miami j collar.A week later, she was transferred back and the miami j collar was removed and the patient was discharged to acute rehabilitation.Wound ostomy saw the patient.The left posterior head pressure ulcer was stage 3.The right areas were still unchangeable.Four months after the accident, the patient was discharged home with home health services.The skin under the miami j collar should be assessed every shift.Based on the ifu the pads should be changed daily but this was not the current practice in critical care and has since been implemented.Transcribed from medwatch (b(4).

• Brand Name: MIAMI J COLLAR
• Type of Device: ORTHOSIS, CERVICAL
• Manufacturer (Section D): OSSUR; blvd hector teran teran 2102; edificio #1, col. de canon del; tijuana, baja california 2102 ; MX 2102
• Manufacturer (Section G): OSSUR; blvd hector teran teran 2102; edificio #1, col. de canon del; tijuana, baja california 2102 ; MX 2102
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9492757557
• MDR Report Key: 6117749
• MDR Text Key: 60549848
• Report Number: 3008523132-2016-00005
• Device Sequence Number: 1
• Product Code: IQK
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: MJ-400
• Device Catalogue Number: MJ-400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 140