Brand Name | PORTEX TT PCT GRIGGS |
Type of Device | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) |
Manufacturer (Section G) |
|
MDR Report Key | 13453962 |
MDR Text Key | 285074377 |
Report Number | 3012307300-2022-02566 |
Device Sequence Number | 1 |
Product Code |
BTO
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K173912 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/04/2022 |
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 |
Health Professional
|
Device Catalogue Number | 100/543/070CZ |
Device Lot Number | 3954718 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/08/2022 |
Initial Date FDA Received | 02/04/2022 |
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
|
Patient Sequence Number | 1 |
|
|