Brand Name | UCENTUM |
Type of Device | CROSSLINK |
Manufacturer (Section D) |
ULRICH GMBH & CO. KG |
buchbrunnenweg 12 |
ulm, 89081 |
GM 89081 |
|
MDR Report Key | 8950393 |
MDR Text Key | 156131385 |
Report Number | 3005823819-2019-00008 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 04052536080854 |
UDI-Public | 4052536080854 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/30/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/30/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | CS 3810-01 |
Device Catalogue Number | CS 3810-01 |
Device Lot Number | U005883 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 08/01/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/30/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
|
|