MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-13 for MIAMI J COLLAR MJP-0871 manufactured by Ossur Americas.
[94950149]
Provider ordered soft collar for patient due to potential neck trauma in case of patient with altered mental status with unknown etiology. I retrieved a collar that was still in its original packaging, when packaging was opened, it did not contain the front half of the collar. Removed the collar from circulation and retrieved another (which was the last in stock). Created situation of an unsafe condition that could have significantly delayed application of a necessary medical device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073957 |
| MDR Report Key | 7116558 |
| Date Received | 2017-12-13 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-12-08 |
| Date Added to Maude | 2017-12-14 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | MIAMI J COLLAR |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2017-12-13 |
| Model Number | MJP-0871 |
| Lot Number | MX170925 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR AMERICAS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-13 |