FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-REVERSE
MDR report key: 2462719
·
Received February 14, 2012
Report
- Report Number
- 1518293-2012-00023
- Event Type
- Malfunction
- Date Received
- February 14, 2012
- Date of Event
- January 20, 2012
- Report Date
- February 14, 2012
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- KQS
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 REPORTS VIA PHONE THAT DURING AN UNSPECIFIED UROLOGY PROCEDURE WITH A FEMALE PATIENT, THE FLUORO FAILED. CUSTOMER REPORTS THE PHYSICIAN COMPLETED THE PROCEDURE BY USE OF ENDOSCOPY. CUSTOMER PROVIDED NO FURTHER INFORMATION OTHER THAN TO SAY THE PROCEDURE WAS COMPLETED AND PATIENT IS FINE.
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 |