MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-11-08 for INTEGRA manufactured by Integra.
[2641454]
The surgeon placed the pt's head into the mayfield headrest. The surgeon tightened the headrest against the pt's skull until the device registered engagement at the appropriated pressure. At that time, the pt's head slipped out of the headrest. The pt incurred a 3 cm laceration requiring several staples for closure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2594611 |
| MDR Report Key | 2594611 |
| Report Source | 99 |
| Date Received | 2010-11-08 |
| Date of Report | 2010-11-04 |
| Date of Event | 2010-10-21 |
| Date Facility Aware | 2010-10-21 |
| Report Date | 2010-11-04 |
| Date Reported to FDA | 2010-11-04 |
| Date Reported to Mfgr | 2010-11-04 |
| Date Added to Maude | 2012-06-05 |
| 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 | RISK MANAGER |
| 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 | INTEGRA |
| Generic Name | MAYFIELD HEADREST |
| Product Code | HBM |
| Date Received | 2010-11-08 |
| Lot Number | 99 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA |
| Manufacturer Address | 311 ENTERPRISE DR PLAINSBORO NH 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-11-08 |