MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-15 for MAYFIELD UNK 19-1040 manufactured by Omi Surgical Products.
[68229]
Pt placed in skull pins with mayfield headrest. During surgery the pt's head slipped out of the mayfield headrest. The headrest was removed and reapplied. It was believed that the headrest was adjusted no tighter than previously; however, the pt's head remained in place and the surgery was completed. The pt was not seriously injured, but received a laceration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011890 |
| MDR Report Key | 113527 |
| Date Received | 1997-08-15 |
| Date of Report | 1997-08-04 |
| Date of Event | 1997-08-01 |
| Date Added to Maude | 1997-08-19 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAYFIELD |
| Generic Name | HEADREST |
| Product Code | HBM |
| Date Received | 1997-08-15 |
| Model Number | UNK |
| Catalog Number | 19-1040 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 111450 |
| Manufacturer | OMI SURGICAL PRODUCTS |
| Manufacturer Address | 4900 CHARLEMAR DR. CINCINNATI OH 45227 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-08-15 |