Brand Name | PDS II (POLYDIOXANONE) SUTURE |
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, co |
l salvacar |
ciudad juarez 32604 |
MX
32604
|
|
Manufacturer Contact |
kenneth
clark
|
route 22 westp o box 151 |
somerville, NJ 08876
|
9082183547
|
|
MDR Report Key | 5769874 |
MDR Text Key | 48780868 |
Report Number | 2210968-2016-10171 |
Device Sequence Number | 1 |
Product Code |
NEW
|
Combination Product (y/n) | N |
PMA/PMN Number | N18331 |
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 |
Report Date |
03/29/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/05/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/31/2020 |
Device Catalogue Number | Z771D |
Device Lot Number | KAK281 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/10/2016 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 06/10/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/25/2016 |
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 |