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 |