MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-25 for MIAMI J COLLAR MJ-400 manufactured by Ossur.
[39090107]
Patient Sequence No: 1, Text Type: N, H10
[39090108]
Patient was placed in a miami jto neck collar due to traumatic injury. The patient developed ulcers along the jaw line within 24 hours of wearing the collar. The initial ulcer reported was offloaded by the hospital by adding/changing the padding configuration.
Patient Sequence No: 1, Text Type: D, B5
[40557781]
Patient Sequence No: 1, Text Type: N, H10
[40557782]
Patient was placed in a miami jto neck collar due to traumatic injury. The patient developed ulcers along the jaw line within 24 hours of wearing the collar. The initial ulcer reported was off loaded by the hospital by adding/changing the padding configuration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2016-00002 |
| MDR Report Key | 5461746 |
| Date Received | 2016-02-25 |
| Date of Report | 2016-03-16 |
| Date Mfgr Received | 2016-02-03 |
| Date Added to Maude | 2016-02-25 |
| 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 | 9493823741 |
| 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 | 2016-02-25 |
| Model Number | MJ-400 |
| Catalog Number | MJ-400 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-02-25 |