N
Patient 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.
MAUDE MDR 9881910
- MDR report key
- 9881910
- Report number
- 8040459-2020-00020
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- AVI KLUGER
- Address
- 5920 LONGBOW DRIVE BOULDER CO 80301 US
- Phone
- 303-303-3035
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CURITY | TUBE, TRACHEAL (W/WO CONNECTOR) | KENDALL GAMMATRON, THAILAND | BTR | 9336E | 9336E | 1902657FED | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-26 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, THE DEVICE WAS TOO SOFT AND TRIED THE INTUBATION FOR THREE TIMES TO THE NEONATAL PREMATURE PATIENT, BUT CONSEQUENTLY THERE WAS AN INJURY IN MUCOUS MEMBRANE AND THEY HAD TO REANIMATE NEONATAL PATIENT.