Brand Name | DERMABOND PRINEO 22CM SKIN CLOSURE |
Type of Device | SURGICAL SEALANT |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville 08876 0151 |
|
Manufacturer (Section G) |
ETHICON INC. SAN LORENZO |
road 183, km. 8.3 |
|
san lorenzo PR 00754 |
|
Manufacturer Contact |
darlene
kyle
|
p.o. box 151, route 22 west |
somerville 08876-0151
|
9082182792
|
|
MDR Report Key | 7143867 |
MDR Text Key | 95923627 |
Report Number | 2210968-2017-71940 |
Device Sequence Number | 1 |
Product Code |
OMD
|
UDI-Device Identifier | 10705031230996 |
UDI-Public | 10705031230996 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K133864 |
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,Followup |
Report Date |
01/09/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/22/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 08/16/2019 |
Device Catalogue Number | CLR222US |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/09/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 09/28/2017 |
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 |
|
|