FDA Adverse Event
Malfunction
Summary report: N
HT EXT DR FINAL ASSY-STANDARD
MDR report key: 2431864
·
Received January 3, 2012
Report
- Report Number
- 1518293-2011-00251
- Event Type
- Malfunction
- Date Received
- January 3, 2012
- Date of Event
- December 18, 2011
- Report Date
- January 3, 2012
- Manufacturer
- LIEBEL-FLARSHEIM BUSINESS
- Product Code
- KQS
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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) 2011: CUSTOMER REPORTS VIA PHONE THAT SYSTEM LOCKED UP DURING A RETROGRADE CYSTOGRAM. PT PROCEDURE WAS COMPLETED USING A PORTABLE FLUORO C-ARM. NO PT INJURY TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HT EXT DR FINAL ASSY-STANDARD | KQS | LIEBEL-FLARSHEIM BUSINESS | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |