MAUDE Adverse Event Report: RESTORATIVE CARE OF AMERICA, INC. MPO ACTIVE; JOINT, ANKLE, EXTERNAL BRACE

Model Number 09MP-L

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

Patient Problems Pain (1994); Tissue Damage (2104); Pressure Sores (2326); Low Oxygen Saturation (2477)

Event Date 08/18/2015

Event Type  malfunction  

Event Description

An elderly female was brought the emergency department following a traumatic motor vehicle accident.She was immediately assessed, including placement of a miami j collar, and emergently taken for orthopedic surgery due to significant blood loss from an open fracture of her right lower extremity.Following surgery, she was also found to have suffered bilateral rib fractures and thoracic and cervical fractures.Neurosurgery was consulted and she was found to have an unstable thoracic spinal cord injury.The patient was on strict bed rest with log-rolling until she was ordered to lie flat with no log rolling.She was fitted for a new miami j collar.A few days later, multiple blisters are noted on the patient's mid-back/spine and mepilex was applied.Multipodus boots were also placed on the patient.A few days later, she underwent a spinal fusion.The patient's activity level was ordered for progressive ambulation.The patient was first seen by the wound ostomy team for skin issue related to moisture and sheering on the buttocks.The wound ostomy team closely followed the patient every 2-4 days until discharge.The patient was also noted to have an unstageable pressure ulcer on her mid-back a few days later.The multipodus boots were rarely in place.Occasionally, it was documented that the patient was refusing to wear them.A month after the mva, the patient was transferred to (b)(6) respiratory.She required 2-3 staff to assist for turning.A few days later her o2 saturations began to decrease and she was requiring increased suctioning and was transferred back to the icu.A few weeks later, the patient's left heel was noted to have an unstageable pressure ulcer.The patient told the wound ostomy rn that the multipodus boots caused more pain on her heel and she requested that her heels be elevated on pillows instead.An unstageable pressure ulcer was also noted on the patient's right occipital area at the edge of where the miami j collar rests two months after the accident.An unstageable pressure ulcer was noted on the patient's left occipital area also believed to be related to the miami j collar.She was transferred back to grant 6 respiratory.Almost 3 months after the mva, 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 iii.The right areas were still unstageable.A few weeks later the patient was discharged home with home health services.

• Brand Name: MPO ACTIVE
• Type of Device: JOINT, ANKLE, EXTERNAL BRACE
• Manufacturer (Section D): RESTORATIVE CARE OF AMERICA, INC.; 12221 33rd st n; saint petersburg FL 33716
• MDR Report Key: 6016362
• MDR Text Key: 56971210
• Report Number: 6016362
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 09MP-L
• Device Catalogue Number: 09MP-L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2016
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS; NO
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 133