Brand Name | UCENTUM |
Type of Device | SCREWDRIVER FOR LOCKING SCREW, COUPLING V |
Manufacturer (Section D) |
ULRICH GMBH & CO. KG |
buchbrunnenweg 12 |
ulm, 89081 |
GM 89081 |
|
Manufacturer (Section G) |
ULRICH GMBH & CO. KG |
buchbrunnenweg 12 |
na |
ulm, 89081 |
GM
89081
|
|
Manufacturer Contact |
christoph
ulrich
|
buchbrunnenweg 12 |
na |
ulm, baden-württemberg 89081
|
GM
89081
|
|
MDR Report Key | 8773541 |
MDR Text Key | 150531674 |
Report Number | 9612420-2019-00046 |
Device Sequence Number | 1 |
Product Code |
NKB
|
UDI-Device Identifier | 04052536081707 |
UDI-Public | 4052536081707 |
Combination Product (y/n) | N |
Reporter Country Code | DA |
PMA/PMN Number | K123717 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
07/09/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | CS 3851-02 |
Device Catalogue Number | CS 3851-02 |
Device Lot Number | U005690 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/02/2019 |
Initial Date FDA Received | 07/09/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/05/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
|
|