FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY, RE , FDP
MDR report key: 4223798
·
Received August 5, 2014
Report
- Report Number
- 1518293-2014-00084
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- July 14, 2014
- Report Date
- July 14, 2014
- Manufacturer
- LIEBEL-FLARSHEIM COMPANY
- Product Code
- MQB
- PMA / PMN Number
- K121838
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
CUSTOMER STATES DURING A RETROGRADE CYSTOGRAM ON A MALE PATIENT, OF UNKNOWN AGE, THEY LOST FLUORO AND THE SYSTEM MESSAGE STATED INTERNAL ERROR. STAFF WAS ABLE TO COMPLETE THE PROCEDURE USING ENDOSCOPY. NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456059 | HUT EXT DR FINAL ASSY, RE , FDP | 90 MQB | MQB | LIEBEL-FLARSHEIM COMPANY | HUB EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |