MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for MAYFIELD? A2003 C10004834 manufactured by Integra Lifesciences Corporation.
[180610730]
A patient sustained a 3-inch laceration during a surgery to the front upper left side of the head from one of the mayfield pins. This occurred while repositioning the patient from supine to prone using the radiolucent mayfield headrest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9744388 |
| MDR Report Key | 9744388 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-01-22 |
| Report Date | 2020-02-18 |
| Date Reported to FDA | 2020-02-18 |
| Date Reported to Mfgr | 2020-02-24 |
| Date Added to Maude | 2020-02-24 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAYFIELD? |
| Generic Name | HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) |
| Product Code | HBL |
| Date Received | 2020-02-24 |
| Model Number | A2003 |
| Catalog Number | C10004834 |
| Lot Number | 4-37-C-1073 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 4900 CHARLEMAR DRIVE BUILDING A CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-24 |