MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-11 for MIAMI J COLLAR MJ400 15776 manufactured by Ossur Americas.
[56970683]
Patient Sequence No: 1, Text Type: N, H10
[56970684]
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 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 a spinal fusion. A few days later, the patient's activity level was ordered for progressive ambulation and the patient was transferred to med/surg. She required 2-3 staff to assist for turning. After the transfer, her o2 saturations began to decrease and she was requiring increased suctioning and was transferred back to the icu. 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 to (b)(6) respiratory 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 iii. The right areas were still unstageable. Four months after the accident, the patient was discharged home with home health services.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6016359 |
| MDR Report Key | 6016359 |
| Date Received | 2016-10-11 |
| Date of Report | 2016-09-29 |
| Date of Event | 2015-08-21 |
| Report Date | 2016-09-29 |
| Date Reported to FDA | 2016-09-29 |
| Date Reported to Mfgr | 2016-09-29 |
| Date Added to Maude | 2016-10-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIAMI J COLLAR |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2016-10-11 |
| Model Number | MJ400 |
| Catalog Number | 15776 |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR AMERICAS |
| Manufacturer Address | 742 PANCHO RD. CAMARILLO CA 93012 US 93012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-11 |