FDA Adverse Event
Injury
Summary report: N
TUBE, TRACHEAL (W/WO CONNECTOR)
MDR report key: 8005320
·
Received October 25, 2018
Report
- Report Number
- 8040459-2018-00078
- Event Type
- Injury
- Date Received
- October 25, 2018
- Date of Event
- September 28, 2018
- Report Date
- December 7, 2018
- Manufacturer
- KENDALL GAMMATRON, THAILAND
- Product Code
- BTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 UNIT COULD NOT BE INFLATED. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 846381 | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | KENDALL GAMMATRON, THAILAND | 9475E | 1735217FED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |