MICRO CHPV W RICKHAM UNITIZED
Report
- Report Number
- 3013886523-2024-00339
- Event Type
- Injury
- Date Received
- November 5, 2024
- Report Date
- July 10, 2025
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- JXG
- UDI-DI
- 10381780519164
- PMA / PMN Number
- NI
- Adverse Event
- 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 (ID 823113) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
CORRECTED FIELDS: B1, H6/F10 (MEDICAL DEVICE PROBLEM). ADDITIONAL INFORMATION RECEIVED: - REACTION ONSET: JULY 2023. - DESCRIBE REACTIONS: 1. HEAD SWELLING, SWELLING FACE - (B)(6) 2023. 2. DEVICE BLOCKAGE, DEVICE OCCLUSION. - OTHER RELEVANT HISTORY: SHUNT SURGERY - (B)(6) 2023. - CODMAN HAKIM PROGRAMMABLE VALVE - USE FOR UNKNOWN INDICATION.
A FACILITY REPORTED HEAD SWELLING AT THE PART OF BURR OF A HAKIM VALVE (UNKNOWN ID). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
N/A.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1460867 | MICRO CHPV W RICKHAM UNITIZED | CHPV | JXG | INTEGRA LIFESCIENCES MANSFIELD | 10381780519164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |