Brand Name | SONICWELD RX |
Type of Device | SONICPIN |
Manufacturer (Section D) |
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
kolbinger strasse 10 |
muehlheim/donau, 78570 |
GM 78570 |
|
Manufacturer (Section G) |
KLS MARTIN L.P. |
p.o. box 16369 |
|
jacksonville FL 32245 |
|
Manufacturer Contact |
jennifer
damato
|
p.o. box 16369 |
jacksonville, FL 32245
|
9046417746
|
|
MDR Report Key | 12964190 |
MDR Text Key | 281973208 |
Report Number | 9610905-2021-00112 |
Device Sequence Number | 1 |
Product Code |
JEY
|
UDI-Device Identifier | 10888118001044 |
UDI-Public | (01)10888118001044 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K080862 |
Exemption Number | 2017029 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/09/2021 |
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 | 52-516-54-04 |
Device Lot Number | SEE H10 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/09/2021 |
Initial Date FDA Received | 12/08/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Other;
|
Patient Age | 6 MO |
Patient Sex | Female |
|
|