MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-16 for ASPEN VISTA COLLAR 984000 manufactured by Aspen Medical Products.
[114018090]
Trauma patient in c-collar for extended period of time, developed pressure injuries to the occipital area of posterior head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7689417 |
| MDR Report Key | 7689417 |
| Date Received | 2018-07-16 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-04-10 |
| Report Date | 2018-07-10 |
| Date Reported to FDA | 2018-07-10 |
| Date Reported to Mfgr | 2018-07-16 |
| Date Added to Maude | 2018-07-16 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPEN VISTA COLLAR |
| Generic Name | SPINAL ORTHOTICS |
| Product Code | IQE |
| Date Received | 2018-07-16 |
| Catalog Number | 984000 |
| Lot Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN MEDICAL PRODUCTS |
| Manufacturer Address | 6481 OAK CANYON IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-16 |