FDA Adverse Event
Malfunction
Summary report: N
MOTION HYBRID WIRE GUIDE
MDR report key: 24957988
·
Received April 22, 2026
Report
- Report Number
- 3008988055-2026-00004
- Event Type
- Malfunction
- Date Received
- April 22, 2026
- Date of Event
- January 27, 2026
- Report Date
- April 22, 2026
- Manufacturer
- HERAEUS MEDICAL COMPONENTS LLC
- Product Code
- EZB
- UDI-DI
- 00827002448469
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT THE DEVICE HAS MALFUNCTIONED OR THAT THE DEVICE WAS RELATED TO A DEATH OR INJURY. DEVICE WAS NOT RETURNED TO MANUFACTURER AND THE INVESTIGATION IS CONCLUDED.
Description of Event or Problem · 0
IT WAS REPORTED "DATE OF EVENT: 27JAN2026 CUSTOMER: ST (B)(6) [UNITED STATES] BLUE COATING SCRAPED OFF AND ENDED UP INTO THE PATIENT'S URETHRA. UNKNOWN IF THE DEVICE WAS RETRIEVED OR NOT. IMAGE OF COMPLAINT DEVICE SUPPLIED SEPARATELY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 512098 | MOTION HYBRID WIRE GUIDE | STYLET FOR CATHETER, GASTRO-UROLOGY | EZB | HERAEUS MEDICAL COMPONENTS LLC | SP-4113-001 | 00827002448469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |