FDA Adverse Event
Summary report: N
DOPPLER PROBE
MDR report key: 7151649
·
Received December 28, 2017
Report
- Report Number
- 0001937397-0001-01117
- Date Received
- December 28, 2017
- Date of Event
- September 7, 2017
- Report Date
- November 30, 2017
- Product Code
- JOP
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON 11/3/2017 KOVEN RECEIVED THE MEDWATCH FORM IN THE MAIL. ON 11/3/2017 PHONE CALL TO INITIAL REPORTER, NO ANSWER, NO VOICE MAIL. ON 11/6/2017 EMAILED INITIAL REPORTER TO CONTACT KOVEN RIGHT AWAY. ON 11/7/2017 HOSPITAL CONTACTED KOVEN AND KOVEN REQUESTED THE PROBE BE RETURNED FOR EVALUATION AND REPLACED PROBE AT NO CHARGE. INVESTIGATION WAS COMPLETED ON THE PROBE AND IT WAS FOUND TO BE WORKING PROPERLY. NO ISSUES WERE FOUND WITH THE PROBE. NO WAY OF UNCOVERING WHY IT DID NOT WORK AT THE HOSPITAL SITE.
Description of Event or Problem · 1
HOSPITAL SAID THEY PLUGGED IN THE PROBE AND IT DID NOT WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 929862 | DOPPLER PROBE | JOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |