MICRO CHPV UNITIZED
Report
- Report Number
- 3013886523-2024-00386
- Event Type
- Injury
- Date Received
- December 13, 2024
- Date of Event
- November 25, 2024
- Report Date
- March 21, 2025
- Manufacturer
- INTEGRA LIFESCIENCES SWITZERLAND SAR
- Product Code
- JXG
- UDI-DI
- 10381780519164
- PMA / PMN Number
- K221840
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
THE HAKIM VALVE WAS RETURNED FOR EVALUATION. DHR - LOT 6263530, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NO DEFECT WAS NOTED. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX AND PRESSURE. ROOT CAUSE - NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE, AT THE TIME OF INVESTIGATION NO PROGRAMMING ISSUES WERE NOTED.
A FACILITY REPORTED A HAKIM VALVE (ID 823114) COULD NOT BE ADJUSTED; THEREFORE IT WAS REMOVED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2407650 | MICRO CHPV UNITIZED | CHPV | JXG | INTEGRA LIFESCIENCES SWITZERLAND SAR | 10381780519164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |