FDA Adverse Event
Malfunction
Summary report: N
CURITY
MDR report key: 14187760
·
Received April 22, 2022
Report
- Report Number
- 8040459-2022-00012
- Event Type
- Malfunction
- Date Received
- April 22, 2022
- Date of Event
- March 31, 2022
- Report Date
- April 22, 2022
- Manufacturer
- KENDALL GAMMATRON, THAILAND
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K892432. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 0
ACCORDING TO THE REPORTER, DURING USE, THE CUFF HAD AN INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 742584 | CURITY | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | KENDALL GAMMATRON, THAILAND | 9475E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |