FDA Adverse Event
Injury
Summary report: N
CURITY
MDR report key: 8439643
·
Received March 21, 2019
Report
- Report Number
- 8040459-2019-00037
- Event Type
- Injury
- Date Received
- March 21, 2019
- Date of Event
- February 26, 2019
- Report Date
- March 21, 2019
- Manufacturer
- KENDALL GAMMATRON, THAILAND
- Product Code
- BTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
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 · 1
ACCORDING TO THE REPORTER, THE DEVICE'S AIR BAG WAS LEAKED. THE PATIENT HAD A TUBE REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232310 | CURITY | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | KENDALL GAMMATRON, THAILAND | 9475E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |