FDA Adverse Event
Malfunction
Summary report: N
RFTL
MDR report key: 20556646
·
Received October 29, 2024
Report
- Report Number
- 9611612-2024-00024
- Event Type
- Malfunction
- Date Received
- October 29, 2024
- Date of Event
- September 30, 2024
- Report Date
- November 14, 2024
- Manufacturer
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Product Code
- GXI
- UDI-DI
- 04048223050187
- PMA / PMN Number
- K060397
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
EVENT TOOK PLACE IN BELGIUM. THIS PRODUCT ANALYSIS WAS CARRIED OUT ON THE BASIS OF ALL THE INFORMATION PROVIDED AND THE INTERNAL REVIEW AT PAJUNK. BASED ON ANALYSIS, RISK ASSESSMENT, RISK PROFILE AND CLINICAL MONITORINGTHIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.
Additional Manufacturer Narrative · 0
IRN# (B)(4). INITIAL BATCH REVIEW DOES NOT INDICATE ANY ADVERSE CONCLUSION. ALL PARAMETERS WITHIN SPECIFICATION.
Description of Event or Problem · 0
IRN# (B)(4). EVENT OCCURRED IN BELGIUM. TENTITIVE DESCRIPTION OF EVENT: SKIN BURNS DURING PROCEDURE.
Description of Event or Problem · 0
IRN# (B)(4). EVENT OCCURRED IN BELGIUM: TENTITIVE DESCRIPTION OF EVENT: SKIN BURNS DURING PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303423 | RFTL | RFTL CANNULA/ PROBE, RADIOFREQUENCY LESION PRODUCT CODE: GXI | GXI | PAJUNK GMBH MEDIZINTECHNOLOGIE | 001165-22C | 1514 | 04048223050187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |