FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 14033298
·
Received April 6, 2022
Report
- Report Number
- 3011610434-2022-00006
- Event Type
- Malfunction
- Date Received
- April 6, 2022
- Date of Event
- March 1, 2022
- Report Date
- April 6, 2022
- Manufacturer
- INNOVATIVE HEALTH, LLC.
- Product Code
- OWQ
- UDI-DI
- 10841898123252
- PMA / PMN Number
- K202042
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INNOVATIVE HEALTH, LLC BECAME AWARE ON 07-MAR-2022 OF A REPORT FROM (B)(6) ON A VIEWFLEX XTRA ICE DEVICE THAT EXPERIENCED A TIP FRACTURE. THE DEVICE WAS RECEIVED WITH A CUT SERIAL TAG WHICH DID NOT ALLOW THE DEVICE TO BE IDENTIFIED. MULTIPLE ATTEMPTS WERE MADE TO GATHER MORE INFORMATION PERTAINING TO THE IDENTITY OF THE DEVICE, AND AT WHAT POINT IN TIME THE FRACTURE WAS IDENTIFIED. NO INFORMATION WAS ABLE TO BE PROVIDED. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR EVALUATION ON 07-MAR-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 BROKEN. NO PATIENT INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2049182 | NA | DIAGNOSTIC ULTRASOUND CATHETER | OWQ | INNOVATIVE HEALTH, LLC. | D087031 | 10841898123252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |