FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 2447147
·
Received January 31, 2012
Report
- Report Number
- 1518293-2012-00009
- Event Type
- Malfunction
- Date Received
- January 31, 2012
- Date of Event
- January 10, 2012
- Report Date
- January 31, 2012
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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
ON (B)(6): CUSTOMER REPORTED VIA PHONE THAT THE UROLOGY SYSTEM WILL NOT FLUORO. STAFF NOTED THE FAILURE AT THE BEGINNING OF DAYS PROCEDURE. CUSTOMER STATED SYSTEM IS CURRENTLY DOWN AND THEY ARE UNABLE TO PERFORM PROCEDURES AS THEY DO NOT HAVE BACK-UP CAPABILITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUT EXT DR FINAL ASSY-REVERSE | KQS | LIEBEL-FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |