FDA Adverse Event
Malfunction
Summary report: N
CUSA EXCEL 36KHZ CEM NOSECONE
MDR report key: 3960080
·
Received June 23, 2014
Report
- Report Number
- 3006697299-2014-00054
- Event Type
- Malfunction
- Date Received
- June 23, 2014
- Report Date
- May 27, 2014
- Manufacturer
- INTEGRA LIFESCIENCES IRELAND LIMITED
- Product Code
- LFL
- PMA / PMN Number
- K981262
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
AT INCOMING INSPECTION OF GOODS BY THE DISTRIBUTOR, THE PACKAGE WAS FOUND WITH FOREIGN MATERIAL INSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364655 | CUSA EXCEL 36KHZ CEM NOSECONE | ULTRASONIC SURGICAL PRODUCTS | LFL | INTEGRA LIFESCIENCES IRELAND LIMITED | 1133618 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |