MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-26 for AMSCO QUANTUM MAYFIELD HEADREST 4-1-C-1216/1464L/1464R manufactured by Steris Corp.
[16297463]
Dr noticed head slip as he began procedure. Found mayfield headrest had loosened and allowed head to drop. Pt's nose was resting against metal knob. Pin had caused tear in temporal region, some bleeding was noted and sutured. After making adjustments, the procedure was completed without incident. Found one knob was not tightened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 168713 |
| MDR Report Key | 168713 |
| Date Received | 1998-05-26 |
| Date of Report | 1998-05-26 |
| Date of Event | 1998-05-21 |
| Date Facility Aware | 1998-05-21 |
| Report Date | 1998-05-26 |
| Date Reported to FDA | 1998-05-26 |
| Date Reported to Mfgr | 1998-05-26 |
| Date Added to Maude | 1998-05-27 |
| 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 | AMSCO QUANTUM MAYFIELD HEADREST |
| Generic Name | HEAD/SPINE RESTRAINT |
| Product Code | HBM |
| Date Received | 1998-05-26 |
| Model Number | QUANTUM |
| Catalog Number | 4-1-C-1216/1464L/1464R |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 164120 |
| Manufacturer | STERIS CORP |
| Manufacturer Address | 5960 HEISLEY RD MENTOR OH 44060 US |
| Baseline Brand Name | MULTIPOISE HEADREST |
| Baseline Generic Name | HEARREST, NEUROLOGICAL |
| Baseline Model No | NA |
| Baseline Catalog No | BF03-800 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-05-26 |