MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-09-15 for PRONE HEAD POSITIONER WITH MIRROR 8000HDP manufactured by Vyaire Medical, Inc.
[86348389]
(b)(4). It has been confirmed by vyaire that the complaint sample is not available for evaluation. All known information has been obtained.
Patient Sequence No: 1, Text Type: N, H10
[86348390]
The customer reported "after low back surgery at (b)(6) hospital in (b)(6). It started out as a small irritation than turned into huge blisters as a reaction to the pillow. I'm still having problems with my vision. Today i have an appointment with my doctor and will have him look at my eyes and determine how to proceed with that. I have a two inch scar above the right eye and on an area of my chin where the whiskers can no longer grow as a result of the reaction".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2017-00366 |
| MDR Report Key | 6869740 |
| Report Source | CONSUMER |
| Date Received | 2017-09-15 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-08-02 |
| Date Mfgr Received | 2017-08-16 |
| Date Added to Maude | 2017-09-15 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | CERRADA V NO.85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRONE HEAD POSITIONER WITH MIRROR |
| Generic Name | HEADREST, NEUROSURGICAL |
| Product Code | HBM |
| Date Received | 2017-09-15 |
| Catalog Number | 8000HDP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | CERRADA V?A DE LA PRODUCCI?N NO. 85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-15 |