Brand Name | CERAMO CONCEPT X PUNCH |
Type of Device | MANUAL RONGEUR |
Manufacturer (Section D) |
FEHLING INSTRUMENTS GMBH & CO. KG |
hanauer landstr. 7a |
karlstein, bavaria 63791 |
GM 63791 |
|
Manufacturer (Section G) |
FEHLING INSTRUMENTS GMBH & CO. KG |
hanauer landstr. 7a |
|
karlstein, bavaria 63791 |
GM
63791
|
|
Manufacturer Contact |
ulrike
lindner
|
hanauer landstr. 7a |
karlstein, bavaria 63791
|
GM
63791
|
|
MDR Report Key | 8110919 |
MDR Text Key | 128874976 |
Report Number | 9615005-2018-00002 |
Device Sequence Number | 1 |
Product Code |
HAE
|
UDI-Device Identifier | 04058749086201 |
UDI-Public | (01)04058749086201(10)X16L538CK |
Combination Product (y/n) | N |
PMA/PMN Number | K153243 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
11/20/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/28/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | TEB-2X |
Device Catalogue Number | TEB-2X |
Device Lot Number | X16L538CK |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/15/2018 |
Date Manufacturer Received | 11/08/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/25/2017 |
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 |