Brand Name | OPTISEAL VALVED PTFE PEELABLE INTRODUCER 6F, 13CM |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
GREATBATCH MEDICAL |
2300 berkshire lane |
minneapolis MN 55441 |
|
Manufacturer Contact |
samuel
master
|
2300 berkshire lane |
minneapolis, MN 55441
|
7639518115
|
|
MDR Report Key | 13057474 |
MDR Text Key | 282715729 |
Report Number | 2183787-2021-00113 |
Device Sequence Number | 1 |
Product Code |
DYB
|
UDI-Device Identifier | 10821329001656 |
UDI-Public | (01)10821329001656(11)210811(17)230811(10)W6455235 |
Combination Product (y/n) | N |
Reporter Country Code | CS |
PMA/PMN Number | K093232 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/21/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/21/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/11/2023 |
Device Model Number | 1000093-015 |
Device Lot Number | W6455235 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 11/29/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/11/2021 |
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 |