MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-21 for MIAMI J COLLAR MJ-400 manufactured by Ossur.
[60549847]
Patient Sequence No: 1, Text Type: N, H10
[60549848]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008523132-2016-00005 |
| MDR Report Key | 6117749 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-21 |
| Date of Report | 2016-11-21 |
| Date of Event | 2015-08-21 |
| Date Mfgr Received | 2016-10-20 |
| Date Added to Maude | 2016-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS. KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9492757557 |
| Manufacturer G1 | OSSUR |
| Manufacturer Street | BLVD HECTOR TERAN TERAN 2102 EDIFICIO #1, COL. DE CANON DEL |
| Manufacturer City | TIJUANA, BAJA CALIFORNIA 2102 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 2102 |
| 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 | 2016-11-21 |
| Model Number | MJ-400 |
| Catalog Number | MJ-400 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR |
| Manufacturer Address | BLVD HECTOR TERAN TERAN 2102 EDIFICIO #1, COL. DE CANON DEL TIJUANA, BAJA CALIFORNIA 2102 MX 2102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-21 |