FDA Adverse Event
Malfunction
Summary report: N
PUMP
MDR report key: 17525466
·
Received August 12, 2023
Report
- Report Number
- MW5132407
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- March 24, 2022
- Manufacturer
- CONTECH MEDICAL, INC.
- Product Code
- LKK
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CALLER STATES HUSBAND HAS A CADMAN PUMP THAT IS "NOT DOING WHAT IT IS SUPPOSED TO DO", SO PHYSICIAN IS CONSIDERING REPLACING. (B)(4). 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 |
|---|---|---|---|---|---|---|---|
| 869181 | PUMP | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | CONTECH MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |