Brand Name | SURGIPRO |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
COVIDIEN LP LLC NORTH HAVEN |
195 mcdermott rd |
north haven CT 06473 |
|
Manufacturer (Section G) |
COVIDIEN LP LLC NORTH HAVEN |
195 mcdermott rd |
|
north haven CT 06473 |
|
Manufacturer Contact |
lisa
hernandez
|
60 middletown ave |
north haven, CT 06473
|
2034925563
|
|
MDR Report Key | 7473788 |
MDR Text Key | 106954206 |
Report Number | 1219930-2018-02362 |
Device Sequence Number | 1 |
Product Code |
FTL
|
UDI-Device Identifier | 20884521101422 |
UDI-Public | 20884521101422 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K915526 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/30/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/31/2022 |
Device Model Number | SPMM-35 |
Device Catalogue Number | SPMM-35 |
Device Lot Number | A7A0029X |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/02/2018 |
Initial Date FDA Received | 04/30/2018 |
Date Device Manufactured | 01/03/2017 |
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 |
|
|