Brand Name | XANTOPREN COMFORT MEDIUM |
Type of Device | MATERIAL, IMPRESSION |
Manufacturer (Section D) |
KULZER GMBH - HQ |
leipziger strasse 2 |
hanau, hesse 63450 , |
GM 63450, |
|
Manufacturer (Section G) |
KULZER SRL |
dietrich honold 1 |
claderia c3 |
sacalaz-judetul, timisoara 30737 0 |
RO
307370
|
|
Manufacturer Contact |
matthias
hartmann
|
leipziger strasse 2 |
hanau, hesse 63450-,
|
GM
63450,
|
|
MDR Report Key | 16500637 |
MDR Text Key | 310853959 |
Report Number | 3005665377-2023-00001 |
Device Sequence Number | 1 |
Product Code |
ELW
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K991425 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/07/2023 |
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 Catalogue Number | 50034105 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/07/2023 |
Initial Date FDA Received | 03/08/2023 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 3 MO |
Patient Sex | Male |
|
|