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 |