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 | 5852831 |
MDR Text Key | 51343943 |
Report Number | 9614846-2016-00146 |
Device Sequence Number | 1 |
Product Code |
PAH
|
UDI-Device Identifier | 28032919892120 |
UDI-Public | 28032919892120 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Type of Report
| Initial |
Report Date |
08/04/2016 |
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? |
No
|
Device Operator |
No Information
|
Device Expiration Date | 03/15/2017 |
Device Model Number | 5194001400 |
Device Lot Number | 0847 |
Initial Date Manufacturer Received |
07/20/2016
|
Initial Date FDA Received | 08/08/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/20/2012 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
|
|