MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-11-20 for CUSA EXCEL 36KHZ C2602 manufactured by Integra Neurosciences, Ltd.
[16915020]
Straight handpiece was not cooling off and water drips. Additional info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[16941422]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3006697299-2013-00077 |
MDR Report Key | 3770261 |
Report Source | 06 |
Date Received | 2013-11-20 |
Date of Report | 2013-11-20 |
Date Mfgr Received | 2013-10-29 |
Date Added to Maude | 2014-05-19 |
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 Contact | LINDA SERENTINO |
Manufacturer Street | 315 ENTERPRISE DR |
Manufacturer Phone | 6099365560 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CUSA EXCEL 36KHZ |
Generic Name | ULTROSONIC SURGICAL PRODUCTS |
Product Code | LBK |
Date Received | 2013-11-20 |
Catalog Number | C2602 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INTEGRA NEUROSCIENCES, LTD |
Manufacturer Address | ANDOVER HAMPSHIRE SP104DR UK SP104DR |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2013-11-20 |