MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-05-05 for MIAMI JR. PEDIATRIC COLLAR MJ-P1 manufactured by Ossur.
[44516255]
Information received from medwatch report mailed by fda - attempted contact with hospital for further details on (b)(6). Will continue attempts to gather more information and receive product for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[44516256]
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
[45860434]
Information received from medwatch report mailed by fda - attempted contact with hospital for further details on 4/22, 4/26 and 4/27. Will continue attempts to gather more information and receive product for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[45860435]
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 | 3008523132-2016-00003 |
| MDR Report Key | 5634739 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-05 |
| Date of Report | 2016-05-05 |
| Date of Event | 2016-03-07 |
| Date Mfgr Received | 2016-04-22 |
| Date Added to Maude | 2016-05-05 |
| 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 JR. PEDIATRIC COLLAR |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2016-05-05 |
| Model Number | MJ-P1 |
| Catalog Number | MJ-P1 |
| 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 | 2016-05-05 |