MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-08-29 for MAYFIELD SWIVEL HORSESHOE HEADREST A1012 manufactured by Integra Lifesciences Corporation Oh/usa.
Report Number | 3004608878-2019-00289 |
MDR Report Key | 8948096 |
Report Source | USER FACILITY |
Date Received | 2019-08-29 |
Date of Report | 2019-08-14 |
Date Mfgr Received | 2019-08-14 |
Date Added to Maude | 2019-08-29 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MRS. KIMBERLY SHELLY |
Manufacturer Street | 311 ENTERPRISE DRIVE |
Manufacturer City | PLAINSBORO NJ 08536 |
Manufacturer Country | US |
Manufacturer Postal | 08536 |
Manufacturer Phone | 6099362319 |
Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION OH/USA |
Manufacturer Street | 4900 CHARLEMAR DRIVE |
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 | SKULL CLAMPS AND HEADREST SYSTEMS |
Product Code | HBM |
Date Received | 2019-08-29 |
Returned To Mfg | 2017-10-18 |
Catalog Number | A1012 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-08-29 |