Brand Name | PORTEX |
Type of Device | TRACHEOSTOMY |
Manufacturer (Section D) |
SMITHS MEDICAL INTERNATIONAL, LTD. |
boundary road |
hythe, kent CT21 6JL |
UK CT21 6JL |
|
MDR Report Key | 12054483 |
MDR Text Key | 258035567 |
Report Number | 3012307300-2021-06450 |
Device Sequence Number | 1 |
Product Code |
BTO
|
UDI-Device Identifier | 15019517077360 |
UDI-Public | 15019517077360 |
Combination Product (y/n) | N |
PMA/PMN Number | K173384 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Type of Report
| Initial |
Report Date |
06/23/2021 |
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 |
No Information
|
Device Model Number | 101/815/080 |
Device Catalogue Number | 101/815/080 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/27/2021 |
Initial Date FDA Received | 06/23/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|