Brand Name | UNKNOWN SURGILON |
Type of Device | SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE |
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 | 10042154 |
MDR Text Key | 190480713 |
Report Number | 1219930-2020-01976 |
Device Sequence Number | 1 |
Product Code |
GAR
|
Combination Product (Y/N) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,FOREIG |
Reporter Occupation |
OTHER HEALTH CARE PROFESSIONAL
|
Type of Report
| Initial,Followup |
Report Date |
05/20/2020 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 05/11/2020 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | UNKNOWN SURGILON |
Device Catalogue Number | UNKNOWN SURGILON |
Device LOT Number | MDH745-DLU 03/23 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 05/08/2020 |
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 04/24/2020 |
Was Device Evaluated By Manufacturer? |
No
|
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|