Brand Name | STEERABLE INTRODUCER SHEATH 12F |
Type of Device | STEERABLE INTRODUCER SHEATH |
Manufacturer (Section D) |
FREUDENBERG MEDICAL, LLC |
2301 centennial blvd |
jeffersonville IN 47130 8976 |
|
Manufacturer (Section G) |
FREUDENBERG MEDICAL, LLC |
2301 centennial blvd |
|
jeffersonville IN 47130 8976 |
|
Manufacturer Contact |
larry
bender
|
2301 centennial blvd |
jeffersonville, IN 47130-8976
|
8122802354
|
|
MDR Report Key | 11796590 |
MDR Text Key | 249669630 |
Report Number | 1000121130-2021-00001 |
Device Sequence Number | 1 |
Product Code |
DRA
|
UDI-Device Identifier | 00850004312049 |
UDI-Public | 00850004312049 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K192422 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
05/04/2021 |
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 | SS120065 |
Device Catalogue Number | PN1008533-004 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/06/2021 |
Initial Date FDA Received | 05/10/2021 |
Was Device Evaluated by Manufacturer? |
No
|
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;
|