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 |
UK GU11 1EJ |
|
Manufacturer (Section G) |
TISSUE SCIENCE LABORATORIES |
victoria house, victoria road |
|
aldershot, hampshire GU11 1EJ |
UK
GU11 1EJ
|
|
Manufacturer Contact |
tracy
landers
|
5920 longbow drive |
boulder, CO 80301
|
3035816943
|
|
MDR Report Key | 12068534 |
MDR Text Key | 258410397 |
Report Number | 9617613-2021-00022 |
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 |
06/25/2021 |
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 |
Health Professional
|
Device Model Number | PEL47 |
Device Catalogue Number | PEL47 |
Device Lot Number | 02A16 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/10/2021 |
Initial Date FDA Received | 06/25/2021 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 35 YR |
|
|