Brand Name | UCENTUM |
Type of Device | ROD, DIA 6.0MM, STRAIGHT, LENGTH 45MM |
Manufacturer (Section D) |
ULRICH GMBH AND CO. KG |
buchbrunnenweg 12 |
ulm, baden-wurttemberg 89081 |
GM 89081 |
|
Manufacturer (Section G) |
ULRICH GMBH AND CO. KG |
buchbrunnenweg 12 |
|
ulm, baden-wurttemberg 89081 |
GM
89081
|
|
Manufacturer Contact |
andreas
hilzenbecher
|
buchbrunnenweg 12 |
ulm, baden-wurttemberg 89081
|
GM
89081
|
|
MDR Report Key | 18822296 |
MDR Text Key | 336740846 |
Report Number | 9612420-2024-00001 |
Device Sequence Number | 1 |
Product Code |
NKB
|
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | K123717 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/01/2024 |
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 3807-045 |
Device Catalogue Number | CS 3807-045 |
Device Lot Number | U038012 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/27/2024 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/12/2024 |
Initial Date FDA Received | 03/01/2024 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/01/2024
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/21/2022 |
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 83 YR |
Patient Sex | Male |
Patient Weight | 120 KG |