MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-12-01 for MIAMI J ADVANCED V2 MJA-101 manufactured by Ossur.
[61239373]
Patient wearing miami j advanced neck collar in the hospital experienced blistering and severe skin breakdown at the chin with one full days use. Irritation occured at the mandible support.
Patient Sequence No: 1, Text Type: D, B5
[62858824]
Patient Sequence No: 1, Text Type: N, H10
[62858825]
Patient wearing miami j advanced neck collar in the hospital experienced blistering and severe skin breakdown at the chin with one full days use. Irritation occured at the mandible support.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008523132-2016-00006 |
| MDR Report Key | 6138736 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-01 |
| Date of Report | 2016-12-19 |
| Date Mfgr Received | 2016-11-02 |
| Date Added to Maude | 2016-12-01 |
| 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 ADVANCED V2 |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2016-12-01 |
| Model Number | MJA-101 |
| Catalog Number | MJA-101 |
| Operator | HEALTH PROFESSIONAL |
| 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. Other | 2016-12-01 |