Brand Name | PDS PLUS SUT 18IN(45CM) 4-0 CLR |
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 |
MX
|
|
Manufacturer Contact |
darlene
kyle
|
p.o. box 151, route 22 west |
somerville, NJ 08876-0151
|
9082182792
|
|
MDR Report Key | 7818250 |
MDR Text Key | 118396007 |
Report Number | 2210968-2018-75435 |
Device Sequence Number | 1 |
Product Code |
NEW
|
UDI-Device Identifier | 10705031048478 |
UDI-Public | 10705031048478 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K061037 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/30/2018 |
1 Device 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 | 02/29/2020 |
Device Catalogue Number | PDP507G |
Device Lot Number | MCK464 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/11/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/30/2018 |
Initial Date FDA Received | 08/27/2018 |
Supplement Dates Manufacturer Received | 09/11/2018
|
Supplement Dates FDA Received | 10/03/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/23/2018 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
|
|