FDA Adverse Event
Death
Summary report: N
CODMAN CERTAS ADJUSTABLE BRAIN SHUNT
MDR report key: 10579502
·
Received September 23, 2020
Report
- Report Number
- MW5096826
- Event Type
- Death
- Date Received
- September 23, 2020
- Date of Event
- August 16, 2020
- Report Date
- September 22, 2020
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- JXG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
MY CHILD'S BRAIN SWELLED FOR TWO YEARS AND I INSISTED IT WAS HIS BRAIN SHUNT. THE DOCTORS KEPT SHUTTING ME DOWN. LONG BEHOLD IT KILLED HIM. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1041491 | CODMAN CERTAS ADJUSTABLE BRAIN SHUNT | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | INTEGRA LIFESCIENCES CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Death |