Brand Name | RUSCH TRULED HANDLE, MEDIUM, EUROPE |
Type of Device | LARYNGOSCOPE, RIGID |
Manufacturer (Section D) |
|
MDR Report Key | 10356129 |
MDR Text Key | 201541719 |
Report Number | 8030121-2020-00131 |
Device Sequence Number | 1 |
Product Code |
CCW
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
07/29/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/03/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 09/15/2020 |
Device Catalogue Number | 0055501EU |
Device Lot Number | 190301 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/17/2020 |
Date Manufacturer Received | 09/04/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|