Brand Name | HUDSON HV TRACH |
Type of Device | HUMID-VENT HEAT AND MOISTURE |
Manufacturer (Section D) |
TELEFLEX MEDICAL SDN. BHD. |
perak, west malaysia |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL SDN. BHD. |
lot no : pt2577 jalen perusahaan |
4 kamunting industrial estate |
perak, west malaysia 34600 |
MY
34600
|
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
|
MDR Report Key | 13497529 |
MDR Text Key | 286586221 |
Report Number | 8040412-2022-00040 |
Device Sequence Number | 1 |
Product Code |
BYD
|
UDI-Device Identifier | 04026704348145 |
UDI-Public | 04026704348145 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer,Company Representative,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/19/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | IPN044386 |
Device Catalogue Number | 41112 |
Device Lot Number | KMZ20M0073 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/09/2022 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/19/2022
|
Initial Date FDA Received | 02/09/2022 |
Supplement Dates Manufacturer Received | 03/10/2022
|
Supplement Dates FDA Received | 03/10/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/28/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|