FDA Adverse Event
Malfunction
Summary report: N
CATHETER AND TIP, SUCTION
MDR report key: 18885386
·
Received March 8, 2024
Report
- Report Number
- MW5152620
- Event Type
- Malfunction
- Date Received
- March 8, 2024
- Report Date
- April 2, 2024
- Manufacturer
- SYMMETRY SURGICAL GMBH
- Product Code
- JOL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 04/02/2024 FOR MW5152620 TO UPDATE PROCODE TO JOL AND MANUFACTURER TO SYMMETRY SURGICAL GMBH. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT'S CATHETER WAS OCCLUDED SO THEY WANTED TO PERMANENTLY SHUT DOWN THE PATIENT'S PUMP. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181234 | CATHETER AND TIP, SUCTION | CATHETER AND TIP, SUCTION | JOL | SYMMETRY SURGICAL GMBH | |||
| 2374327 | CATHETER AND TIP, SUCTION | CATHETER AND TIP, SUCTION | JOL | SYMMETRY SURGICAL GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | PROGRAMMABLE INFUSION PUMP IMPLANTED |