FDA Adverse Event
Injury
Summary report: N
SYMBIA INTEVO 16
MDR report key: 19288202
·
Received May 10, 2024
Report
- Report Number
- 1423253-2024-00005
- Event Type
- Injury
- Date Received
- May 10, 2024
- Date of Event
- September 7, 2023
- Report Date
- August 7, 2024
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Product Code
- KPS
- UDI-DI
- 04056869001241
- PMA / PMN Number
- K200474
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED ON APRIL 11, 2024, OF A CUSTOMER SERVICE ENGINEER INJURY THAT OCCURRED ON (B)(6) 2023. ALLEGEDLY, THE ENGINEER SUSTAINED A FRACTURE AND LACERATION INJURY TO HIS FINGER THAT REQUIRED STITCHES, WHILE SERVICING THE DEVICE CONTRARY TO THE SERVICE INSTRUCTIONS. NO LABELING OR PRODUCT DEFECTS WERE FOUND. THE DESCRIBED EVENT CANNOT CAUSE INJURY TO PATIENTS OR OPERATORS WHILE IN CLINICAL USE AT A USER FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 971246 | SYMBIA INTEVO 16 | SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION | KPS | SIEMENS MEDICAL SOLUTIONS USA, INC. | 10764804 | 04056869001241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |