Brand Name | MESH BALLYMONEY - IVS TUNNELLER |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
TYCO HEALTHCARE UK MANF. LTD |
20 garryduff road |
ballymoney,at BT53 7AP |
GB
BT53 7AP |
|
Manufacturer (Section G) |
TYCO HEALTHCARE UK MANF. LTD |
20 garryduff road |
|
ballymoney,at BT53 7AP |
GB
BT53 7AP
|
|
Manufacturer Contact |
lisa
hernandez
|
60 middletown ave. |
north haven, CT 06473
|
2034925563
|
|
MDR Report Key | 10260204 |
MDR Text Key | 198506872 |
Report Number | 6000141-2020-00004 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
01/08/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/10/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 04/30/2006 |
Device Model Number | IVS02 |
Device Catalogue Number | IVS02 |
Device Lot Number | 0302039-13 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 12/16/2020 |
Was Device Evaluated by Manufacturer? |
No Answer Provided
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Treatment Data |
Date Received: 07/10/2020 Patient Sequence Number: 1 |
|
|