FDA Adverse Event
Injury
Summary report: N
INNOVA IGS 520
MDR report key: 14203578
·
Received April 26, 2022
Report
- Report Number
- 9611343-2022-00002
- Event Type
- Injury
- Date Received
- April 26, 2022
- Date of Event
- March 1, 2022
- Report Date
- April 26, 2022
- Manufacturer
- GE MEDICAL SYSTEMS SCS
- Product Code
- OWB
- PMA / PMN Number
- K181403
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 0
THE PATIENT UNDERWENT A LONG EXAM WITH THE INNOVA IGS 520 VASCULAR SYSTEM DURING WHICH HE HAS RECEIVED A HIGH X-RAYS DOSE THAT COULD LEAD TO A SERIOUS INJURY AFTER FEW WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1540381 | INNOVA IGS 520 | INNOVA IGS 520 | OWB | GE MEDICAL SYSTEMS SCS | - |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Male | Other |