MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for CURITY 9335E manufactured by Kendall Gammatron, Thailand.
[186582691]
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
[186582692]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040459-2020-00019 |
| MDR Report Key | 9881908 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-26 |
| Model Number | 9335E |
| Catalog Number | 9335E |
| 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 | 1. Required No Informationntervention | 2020-03-26 |