MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-09 for MAYFIELD 4-22-C 1001 manufactured by Ohio Medical Instruments, Inc..
[24331]
The device's head clamp was applied to the pt cranium and attached to the table attachment. The pt's head slipped, moved and the pins came out of the skin causing a small laceration at one pin site. This required one suture. The head rest was removed and another one used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 34800 |
| MDR Report Key | 34800 |
| Date Received | 1996-05-09 |
| Date of Report | 1996-05-08 |
| Date of Event | 1996-05-06 |
| Date Facility Aware | 1996-05-06 |
| Report Date | 1996-05-09 |
| Date Added to Maude | 1996-08-02 |
| 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 |
| 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 | MAYFIELD |
| Generic Name | MAYFIELD HEADREST 2000 |
| Product Code | HBM |
| Date Received | 1996-05-09 |
| Model Number | 4-22-C 1001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 36180 |
| Manufacturer | OHIO MEDICAL INSTRUMENTS, INC. |
| Manufacturer Address | 3924 VIRGINIA AVE CINCINNATI OH 45227 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-05-09 |