FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 2480332
·
Received February 28, 2012
Report
- Report Number
- 1518293-2012-00025
- Event Type
- Malfunction
- Date Received
- February 28, 2012
- Date of Event
- January 25, 2012
- Report Date
- February 28, 2012
- Manufacturer
- LIEBEL-FLARSHEIM CO
- Product Code
- KQS
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, 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
(B)(6): CUSTOMER REPORTS VIA PHONE THAT STAFF WERE PERFORMING A UROLOGY LITHOTRIPSY STONE REMOVAL ON A PATIENT (GENDER AND AGE NOT PROVIDED) WHEN THE SYSTEM FLUORO FAILED. STAFF MOVED THE PATIENT TO ANOTHER ROOM WHERE THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. NO REPORTED INJURY.
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 |