Brand Name | SKATER ALL-PURPOSE AND NEPHROSTOMY SET LOCKING 8FR X 25CM |
Type of Device | SKATER |
Manufacturer (Section D) |
ARGON MEDICAL DEVICES |
1445 flat creek rd |
athens TX 75751 |
|
Manufacturer Contact |
kelly
mayer
|
1445 flat creek rd |
athens, TX 75751
|
9036759321
|
|
MDR Report Key | 19189304 |
MDR Text Key | 341116298 |
Report Number | 0001625425-2024-00999 |
Device Sequence Number | 1 |
Product Code |
GBO
|
UDI-Device Identifier | 00886333217786 |
UDI-Public | 00886333217786 |
Combination Product (y/n) | N |
Reporter Country Code | SW |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/26/2024 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 756608025 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/27/2024
|
Initial Date FDA Received | 04/26/2024 |
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) |
Required Intervention;
|