FDA Adverse Event
Other
Summary report: N
AURAGEN STRIP 6 CTS
MDR report key: 2426250
·
Received January 13, 2012
Report
- Report Number
- 9612007-2012-00001
- Event Type
- Other
- Date Received
- January 13, 2012
- Report Date
- January 13, 2012
- Manufacturer
- INTEGRA NEUROSCIENCES IMPLANTS S.A.
- Product Code
- GYC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE PRODUCT "INSERT DOES NOT ACCURATELY PORTRAY THE ENCLOSED PRODUCT AND IS MISLEADING AND IT MAKES IT MORE DIFFICULT AND CONFUSING WHEN IDENTIFYING THE LEADS ONCE THEY HAVE BEEN CUT OFF OF THE STRIP FOR REMOVAL". ADDITIONAL CLINICAL INFORMATION WAS REQUESTED AND ON (B)(6), 2012, THE CUSTOMER PROVIDED THE FOLLOWING: THE CUSTOMER WAS NOT AWARE OF ANY PRODUCT COMPLAINTS WITH THE 6 CONTACT STRIP THAT INVOLVED A PT. THE DIAGRAM DOES NOT MATCH THE ACTUAL PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AURAGEN STRIP 6 CTS | AURAGEN STRIP ELECTRODE | GYC | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |