MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-07-10 for CUSA EXCEL 36KHZ STRAIGHT HANDPIECE C2602 manufactured by Integra Lifesciences(ireland).
Report Number | 3006697299-2019-00076 |
MDR Report Key | 8775693 |
Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
Date Received | 2019-07-10 |
Date of Report | 2019-06-13 |
Date Mfgr Received | 2019-07-11 |
Device Manufacturer Date | 2018-12-01 |
Date Added to Maude | 2019-07-10 |
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 | 3 |
Event Location | 3 |
Manufacturer Contact | USER KIMBERLY SHELLY |
Manufacturer Street | 311 ENTERPRISE DRIVE |
Manufacturer City | PLAINSBORO NJ 08536 |
Manufacturer Country | US |
Manufacturer Postal | 08536 |
Manufacturer Phone | 6099362393 |
Manufacturer G1 | INTEGRA LIFESCIENCES(IRELAND) |
Manufacturer Street | IDA BUSINESS&TECHNOLOGY PARK |
Manufacturer City | SRAGH, TULLAMORE, CO.OFFALY |
Manufacturer Country | EI |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CUSA EXCEL 36KHZ STRAIGHT HANDPIECE |
Generic Name | ULTRASONIC SURGICAL PRODUCTS |
Product Code | LBK |
Date Received | 2019-07-10 |
Catalog Number | C2602 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INTEGRA LIFESCIENCES(IRELAND) |
Manufacturer Address | IDA BUSINESS&TECHNOLOGY PARK IDA BUSINESS&TECHNOLOGY PARK SRAGH, TULLAMORE, CO.OFFALY EI |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-07-10 |