FDA Adverse Event
Malfunction
Summary report: N
N/A
MDR report key: 11632006
·
Received April 7, 2021
Report
- Report Number
- 3011610434-2021-00003
- Event Type
- Malfunction
- Date Received
- April 7, 2021
- Report Date
- April 7, 2021
- Manufacturer
- INNOVATIVE HEALTH, LLC.
- Product Code
- OWQ
- UDI-DI
- 10841898123252
- PMA / PMN Number
- K173262
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
INNOVATIVE HEALTH, LLC BECAME AWARE ON 16-MAR-2021 OF A REPORT FROM (B)(6) HOSPITAL ON A VIEWFLEX XTRA ICE DEVICE THAT EXPERIENCED A TIP FRACTURE WHILE THE DEVICE WAS IN USE DURING A PROCEDURE. INNOVATIVE HEALTH RECEIVED THE DEVICE BACK ON 17-MAR-2021. THE FRACTURE ON THE TIP WAS CONFIRMED. INNOVATIVE HEALTH CONTACTED THE HEALTHCARE FACILITY IN TWO DIFFERENT OCCASIONS ON 18-MAR-2021 AND 30-MAR-2021 TO OBTAIN ADDITIONAL DETAILS ABOUT THE INCIDENT. NO ADDITIONAL DETAILS WERE PROVIDED. PATIENT WAS NOT INJURED.
Description of Event or Problem · 1
THE VIEWFLEX CATHETER TIP REPORTEDLY BROKE IN THE PATIENT DURING A CASE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523830 | N/A | DIAGNOSTIC ULTRASOUND CATHETER | OWQ | INNOVATIVE HEALTH, LLC. | D087031 | 10841898123252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |