MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-01 for LERMAN MINERVA A193000SM * manufactured by Trulife, Inc..
[3691094]
An elderly patient with c-2 vertebral body fracture immobilized in lerman minerva brace. Despite padding and custom fitting developed stage 3 pressure ulcer on jaw and stage 2 pressure ulcers on clavicle. What was the original intended procedure? Immobilization of cervical spine. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3207029 |
| MDR Report Key | 3207029 |
| Date Received | 2013-07-01 |
| Date of Report | 2013-07-01 |
| Date of Event | 2013-06-18 |
| Report Date | 2013-07-01 |
| Date Reported to FDA | 2013-07-01 |
| Date Reported to Mfgr | 2013-07-05 |
| Date Added to Maude | 2013-07-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LERMAN MINERVA |
| Generic Name | ORTHOSIS, CERVICAL-THORACIC, RIGID |
| Product Code | IQF |
| Date Received | 2013-07-01 |
| Model Number | A193000SM |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRULIFE, INC. |
| Manufacturer Address | 26296 TWELVE TREES LANE NW POULSBO WA 98370 US 98370 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-07-01 |