MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-02-06 for MAYFIELD SWIVEL HORSESHOE HEADREST A1012 manufactured by Integra Lifesciences Corporation.
[20703254]
To date the device involved in the reported incident has not been received for evaluation. An investigation will be initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[20838309]
The user facility reported that the device slipped. Additional information was requested from the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004608878-2009-00009 |
| MDR Report Key | 1346930 |
| Report Source | 05,06 |
| Date Received | 2009-02-06 |
| Date of Report | 2009-02-06 |
| Date Mfgr Received | 2009-02-02 |
| Date Added to Maude | 2010-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 609936 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 4900 CHARLEMAR DR., |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAYFIELD SWIVEL HORSESHOE HEADREST |
| Generic Name | NONE |
| Product Code | HBM |
| Date Received | 2009-02-06 |
| Catalog Number | A1012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-06 |