MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-05 for MIAMI J MJP2 manufactured by Ossur Usa.
[110082479]
Patient Sequence No: 1, Text Type: N, H10
[110082480]
A young pediatric patient who was a restrained passenger involved in a motor vehicle crash in (b)(6) 2017 was brought to the emergency department (ed) as a trauma. He was found to have bilateral closed head injury, traumatic brain injury, traumatic subarachnoid increased intracranial pressure, declining mental status and enlarging pupil on the left side. Neurosurgery evaluated him, and he was taken to the operating room for a left-sided hemicraniectomy with a right-sided intraparenchymal intracranial pressure monitor. Following the procedure the patient was admitted to the pediatric intensive care unit (picu). A miami-j collar was placed on the patient for him to be in at all times. Twenty-nine days later the order for the miami-j collar was changed to "may substitute soft collar when in bed, miami-j for any mobilization oob". The following day the patient was transferred to a pediatric unit. On the 6th day on the pediatric med-surg department the nurse caring for the patient identified a wound on the right posterior area of his head and identified it as a stage i pressure injury (pi). A provider placed a wound consult to evaluate the area. A wound/ostomy nurse assessed the site that day and identified the wound as an unstageable pi related to the miami-j collar. Per wound consult: to the right shoulder are three stage i pressure injuries that measure approximately 0. 5 cm x 0. 3 cm. All are non-blanching reddened areas and appear to be from the miami j collar. Dad has been placing lambs wool over the shoulder where the miami j is in contact. This appears to be offloading appropriately. To the left shoulder is a linear area of blanchable erythema. Lambs wool is also being applied to this shoulder for protection. Regarding the eschar to the posterior occiput, there is a gel pad at bedside but dad states this is too large for the patient. Orthotics is ordered for assessment of an osscian back. Nursing note from mid (b)(6) reports this was trialed and also too large for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7568604 |
| MDR Report Key | 7568604 |
| Date Received | 2018-06-05 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-01-05 |
| Report Date | 2018-05-31 |
| Date Reported to FDA | 2018-05-31 |
| Date Reported to Mfgr | 2018-06-05 |
| Date Added to Maude | 2018-06-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2018-06-05 |
| Model Number | MJP2 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR USA |
| Manufacturer Address | 27051 TOWNE CENTRE DRIVE SUITE 100 FOOTHILL RANCH CA 92610 US 92610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-05 |