Brand Name | PDS+ VIO 27IN 0 S/A CT-1 |
Type of Device | SUTURE, SURGICAL, ABSORBABLE |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
ETHICON INC.-JUAREZ |
avenida de las torres 7125 |
col salvacar |
ciudad juarez 32604 |
MX
32604
|
|
Manufacturer Contact |
darlene
kyle
|
p.o. box 151, route 22 west |
somerville, NJ 08876-0151
|
9082182792
|
|
MDR Report Key | 8849206 |
MDR Text Key | 152916084 |
Report Number | 2210968-2019-84973 |
Device Sequence Number | 1 |
Product Code |
NEW
|
Combination Product (Y/N) | N |
Reporter Country Code | CO |
PMA/PMN Number | K061037 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,FOREIG |
Reporter Occupation |
|
Type of Report
| Initial |
Report Date |
07/05/2019 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 07/31/2019 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device EXPIRATION Date | 02/29/2020 |
Device Catalogue Number | PDP340H |
Device LOT Number | MCK785 |
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 | 07/05/2019 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 03/26/2018 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
|
Type of Device Usage |
Initial
|
|
|