FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 14861845
·
Received June 29, 2022
Report
- Report Number
- 3011610434-2022-00008
- Event Type
- Malfunction
- Date Received
- June 29, 2022
- Date of Event
- May 25, 2022
- Report Date
- May 31, 2022
- Manufacturer
- INNOVATIVE HEALTH, LLC.
- Product Code
- OWQ
- UDI-DI
- 10841898123252
- PMA / PMN Number
- K202042
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
INNOVATIVE HEALTH, LLC BECAME AWARE ON 31-MAY-2022 OF A REPORT FROM (B)(6) HOSPITAL ON A VIEWFLEX XTRA ICE DEVICE THAT EXPERIENCED A TIP FRACTURE DURING A PROCEDURE. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR EVALUATION ON 03-JUN-2022. UPON INVESTIGATION, THE FRACTURE ON THE DEVICE WAS CONFIRMED. THE TIP DID NOT FALL OFF COMPLETELY AND WAS ATTACHED TO THE SHAFT. NO INJURY WAS REPORTED.
Description of Event or Problem · 0
THE TIP OF THIS DEVICE WAS REPORTED TO HAVE FRACTURED DURING THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2473295 | NA | DIAGNOSTIC ULTRASOUND CATHETER | OWQ | INNOVATIVE HEALTH, LLC. | D087031 | 10841898123252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |