FDA Adverse Event
Malfunction
Summary report: N
BOVIE MEDICAL
MDR report key: 19997614
·
Received August 15, 2024
Report
- Report Number
- 3007208013-2024-00040
- Event Type
- Malfunction
- Date Received
- August 15, 2024
- Report Date
- September 13, 2024
- Manufacturer
- BOVIE MEDICAL CORP.
- Product Code
- HQP
- UDI-DI
- 00607151011017
- PMA / PMN Number
- K121441
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
AWAITING ADDITIONAL INFORMATION AND/OR RETURING OF THE REPORTED DEVICE(S).
Additional Manufacturer Narrative · 0
THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE CUSTOMER WAS UNABLE TO ANSWER SPECIFIC QUESTIONS ABOUT USE OR COMPLETE RETURN OF PRODUCT. TRUE ROOT CAUSE CANNOT BE DETERMINED WITH ACCURACY AT THIS TIME. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.
Description of Event or Problem · 0
THE COMPLAINANT ALLEGES, "OUR UROLOGY PRACTICE HAS HAD 3 BREAK FROM THIS LOT# DURING PROCEDURES."
Description of Event or Problem · 0
THE COMPLAINANT ALLEGES, "OUR UROLOGY PRACTICE HAS HAD 3 BREAK FROM THIS LOT# DURING PROCEDURES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2373119 | BOVIE MEDICAL | CAUTERY | HQP | BOVIE MEDICAL CORP. | AA01 | 1023Z | 00607151011017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |