MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-18 for 7' COMFORT FOAM HEADREST PILLOW REORDER NUMBER: CF-1007 manufactured by Soule Medical, Inc..
[622327]
Patient came from pacu with approximately 8 inch red streak across forehead and swelling to left eye.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 881523 |
MDR Report Key | 881523 |
Date Received | 2007-06-18 |
Date of Report | 2007-06-18 |
Date of Event | 2007-02-28 |
Report Date | 2007-06-18 |
Date Reported to FDA | 2007-06-18 |
Date Added to Maude | 2007-07-18 |
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 |
Reporter Occupation | RISK MANAGER |
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 | 7' COMFORT FOAM HEADREST PILLOW |
Generic Name | FOAM HEADREST |
Product Code | LWG |
Date Received | 2007-06-18 |
Model Number | REORDER NUMBER: CF-1007 |
Catalog Number | REORDER NUMBER: CF-1007 |
Lot Number | REORDER NUMBER: CF-1007 |
ID Number | * |
Device Availability | N |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 860160 |
Manufacturer | SOULE MEDICAL, INC. |
Manufacturer Address | 4322 PET LANE LUTZ FL 33559 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2007-06-18 |