MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-28 for COLLAR CERVICAL MIAMI J P1 MJR-P1 manufactured by Ossur Mexico.
[41222862]
Patient Sequence No: 1, Text Type: N, H10
[41222863]
Patient is status post craniotomy, ventriculostomy and bone flap. Physician ordered a cervical collar. A 2cm x 3cm eschar pressure ulcer noted in the left lower area under cervical collar. Wound care team care initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5528604 |
| MDR Report Key | 5528604 |
| Date Received | 2016-03-28 |
| Date of Report | 2016-03-14 |
| Date of Event | 2016-03-07 |
| Report Date | 2016-03-09 |
| Date Reported to FDA | 2016-03-09 |
| Date Reported to Mfgr | 2016-03-09 |
| Date Added to Maude | 2016-03-28 |
| 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 | COLLAR CERVICAL MIAMI J P1 |
| Generic Name | CERVICAL COLLAR |
| Product Code | IQK |
| Date Received | 2016-03-28 |
| Model Number | MJR-P1 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR MEXICO |
| Manufacturer Address | OSSUR NORTH AMERICA INC 27051 TOWNE CENTRE DRIVE FOOTHILL RANCH CA 92610 US 92610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-28 |