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 | 8765280 |
MDR Text Key | 150172189 |
Report Number | 1219930-2019-03955 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K915526 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
03/09/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/05/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 06/01/2019 |
Device Model Number | SPMM-35 |
Device Catalogue Number | SPMM-35 |
Device Lot Number | A4F0333X |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 02/24/2020 |
Was Device Evaluated by Manufacturer? |
No Answer Provided
|
Date Device Manufactured | 06/09/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Treatment Data |
Date Received: 07/05/2019 Patient Sequence Number: 1 |
|
|