Brand Name | STRATAFIX SPIRAL PDS+ |
Type of Device | SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
ETHICON INC. |
road 183, km. 8.3 |
|
san lorenzo PR |
|
Manufacturer Contact |
darlene
kyle
|
p.o. box 151, route 22 west |
somerville, NJ 08876-0151
|
9082182792
|
|
MDR Report Key | 7515198 |
MDR Text Key | 108292827 |
Report Number | 2210968-2018-72803 |
Device Sequence Number | 1 |
Product Code |
NEW
|
UDI-Device Identifier | 10705031236219 |
UDI-Public | 10705031236219 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/20/2018 |
1 Device was Involved in the Event |
|
1 Patient 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 | 09/30/2019 |
Device Catalogue Number | SXPP1B450 |
Device Lot Number | LLH578 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/08/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/20/2018 |
Initial Date FDA Received | 05/15/2018 |
Supplement Dates Manufacturer Received | 05/08/2018
|
Supplement Dates FDA Received | 06/04/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/18/2017 |
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 |
|
|