Brand Name | MESH TSL - PELVICOL¿ |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
TISSUE SCIENCE LABORATORIES |
victoria house, victoria road |
aldershot, hampshire GU11 1EJ |
GB GU11 1EJ |
|
Manufacturer (Section G) |
TISSUE SCIENCE LABORATORIES |
victoria house, victoria road |
|
aldershot, hampshire GU11 1EJ |
GB
GU11 1EJ
|
|
Manufacturer Contact |
lisa
hernandez
|
60 middletown ave |
north haven, CT 06473
|
2034925563
|
|
MDR Report Key | 8095988 |
MDR Text Key | 128095788 |
Report Number | 9617613-2018-00114 |
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 |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
11/21/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/21/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/04/2002 |
Device Model Number | UNK PELVICOL |
Device Catalogue Number | UNK PELVICOL |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 10/31/2018 |
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) |
Required Intervention;
|
|
|