Brand Name | T-SLING |
Type of Device | URINARY INCONTINENCE SLING |
Manufacturer (Section D) |
HERNIAMESH SRL |
via fratelli meliga 1/c |
chivasso, torino 10034 |
IT 10034 |
|
Manufacturer (Section G) |
HERNIAMESH SRL |
via fratelli meliga 1/c |
|
chivasso, torino 10034 |
IT
10034
|
|
Manufacturer Contact |
selanna
martorana
|
via fratelli meliga 1/c |
chivasso, torino 10034
|
IT
10034
|
9011919623
|
|
MDR Report Key | 6215225 |
MDR Text Key | 63608572 |
Report Number | 9614846-2016-00233 |
Device Sequence Number | 1 |
Product Code |
PAH
|
UDI-Device Identifier | 28032919892120 |
UDI-Public | 28032919892120 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/29/2016 |
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 |
No Information
|
Device Expiration Date | 07/01/2014 |
Device Model Number | 5194001400 |
Device Lot Number | 0650 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/05/2016
|
Initial Date FDA Received | 12/30/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/01/2009 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Congenital Anomaly;
Hospitalization;
Required Intervention;
Disability;
|