MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-02-25 for MAYFIELD INTERGUIDE HORSESHOE HEADREST ASSEMBLY 4-0-1094 A-1094 manufactured by Ohio Medical Instrument Co Inc.
[19492291]
"the type of procedure performed was a posterior fusion. The patient was in a prone position with their face in contact with the jell side of the horse shoe headrest. The jell pads on horse shoe moved inward from patient. Thereby patient really resting on framing of horse shoe not jell pad. The location of the injury was in the area of the forehead and cheek-bilateral, almost entire forehead approximately 1 inch x 3 inch on cheeks. Pressure areas raised and blanced in color, not reddened. No apparent injury to eyes, the resident checked patient in ptcu and in pt unit. Skin normal next morning according to doctor".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525725-2003-00011 |
| MDR Report Key | 445859 |
| Report Source | 05,06 |
| Date Received | 2003-02-25 |
| Date of Report | 2003-02-19 |
| Date of Event | 2003-01-07 |
| Date Facility Aware | 2003-01-07 |
| Report Date | 2003-02-18 |
| Date Reported to Mfgr | 2003-02-18 |
| Date Mfgr Received | 2003-02-18 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2003-03-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | W. WEBBER |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal | 45227 |
| Manufacturer Phone | 5135612241 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAYFIELD INTERGUIDE HORSESHOE HEADREST ASSEMBLY |
| Generic Name | HORSESHOE HEADREST |
| Product Code | HBM |
| Date Received | 2003-02-25 |
| Returned To Mfg | 2003-02-17 |
| Model Number | 4-0-1094 |
| Catalog Number | A-1094 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 19 MO |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 434832 |
| Manufacturer | OHIO MEDICAL INSTRUMENT CO INC |
| Manufacturer Address | 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US |
| Baseline Brand Name | MAYFIELD INTERGUIDE HORSESHOE HEADREST ASSEMBLY |
| Baseline Generic Name | HORSESHOE HEADREST |
| Baseline Model No | 4-0-1094 |
| Baseline Catalog No | A-1094 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-02-25 |