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 2017-08-03 for MIAMI JR. PEDIATRIC COLLAR MJ-P1 manufactured by Ossur Americas, Inc..
[81777820]
Pediatric patient wearing miami jr. Pediatric collar sustained a grade iii skin breakdown in front chin area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2017-00004 |
| MDR Report Key | 6764523 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-03 |
| Date of Report | 2017-11-17 |
| Date Mfgr Received | 2017-07-20 |
| Date Added to Maude | 2017-08-03 |
| 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 |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9492757557 |
| Manufacturer G1 | OSSUR AMERICAS, INC. |
| Manufacturer Street | 27051 TOWNE CENTRE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIAMI JR. PEDIATRIC COLLAR |
| Generic Name | CERVICAL COLLAR |
| Product Code | IQK |
| Date Received | 2017-08-03 |
| 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 AMERICAS, INC. |
| Manufacturer Address | 27051 TOWNE CENTRE FOOTHILL RANCH CA 92610 US 92610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-03 |