FDA Adverse Event
Malfunction
Summary report: N
INTELLICUFF
MDR report key: 17019563
·
Received May 30, 2023
Report
- Report Number
- 3001421318-2023-02064
- Event Type
- Malfunction
- Date Received
- May 30, 2023
- Date of Event
- May 22, 2023
- Report Date
- May 30, 2023
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- BSK
- UDI-DI
- 07630002800839
- PMA / PMN Number
- K150893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- 505
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION IS ONGOING.
Description of Event or Problem · 0
HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION FROM THE DISTRIBUTOR: AN INTELLICUFF IN KWH WAS FOUND THE TUBE CONNECTOR WAS PHYSICALLY DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650135 | INTELLICUFF | INTELLICUFF | BSK | HAMILTON MEDICAL AG | 951001 | 07630002800839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |