FDA Adverse Event
Malfunction
Summary report: N
ACCUDRAIN WITH ANTI-REFLUX VALVE
MDR report key: 1679409
·
Received May 4, 2010
Report
- Report Number
- 2648988-2010-00031
- Event Type
- Malfunction
- Date Received
- May 4, 2010
- Report Date
- May 4, 2010
- Manufacturer
- INTEGRA NEUROSCIENCES PR
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 INFO.
Description of Event or Problem · 1
THE REPORTING FACILITY DESCRIBED THREE EVENTS INVOLVING THE ACCUDRAIN-((B)(4)) DESCRIBED AS "LEAKING" WHILE IN PT USE. ALL THREE INCIDENTS REQUIRED REVISION TO A NEW ACCUDRAIN. THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED AT THE REPORTING FACILITY. NO PT INJURY OCCURRED AS A RESULT OF THE EVENT. ADDITIONAL CLINICAL INFO REQUESTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCUDRAIN WITH ANTI-REFLUX VALVE | NA | JXG | INTEGRA NEUROSCIENCES PR | POSSIBLY 1100408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |