MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-31 for CURITY 9475E manufactured by Kendall Gammatron, Thailand.
[187560247]
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.
Patient Sequence No: 1, Text Type: N, H10
[187560248]
According to the reporter, during intubation, the catheter balloon was pumped, and found out that the balloon could not be inflated and fixed. Intubation could not establish an artificial airway. After extubation, the balloon was found to leak. The catheter was replaced and another one was inserted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040459-2020-00022 |
| MDR Report Key | 9904643 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-29 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-06-03 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | KENDALL GAMMATRON, THAILAND |
| Manufacturer Street | NAKHON CHAI SI DISTRICT |
| Manufacturer City | NAKHON PATHOM |
| Manufacturer Country | TH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURITY |
| Generic Name | TUBE, TRACHEAL (W/WO CONNECTOR) |
| Product Code | BTR |
| Date Received | 2020-03-31 |
| Model Number | 9475E |
| Catalog Number | 9475E |
| Lot Number | 1915420FED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KENDALL GAMMATRON, THAILAND |
| Manufacturer Address | NAKHON CHAI SI DISTRICT NAKHON PATHOM TH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |