Brand Name | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE |
Type of Device | SUTURE, NON-ABSORBABLE |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
ETHICON, INC. SAN LORENZO |
road 183, km 8.3 |
industrial area |
hato PR 00754 |
|
Manufacturer (Section D) |
ETHICON, INC. SAN LORENZO |
road 183, km 8.3 |
industrial area |
hato PR 00754 |
|
Manufacturer (Section G) |
ETHICON, INC. SAN LORENZO |
road 183, km. 8.3 |
industrial area |
hato PR 00754 |
|
Manufacturer Contact |
berkley
pollard
|
route 22 west |
po box 151 |
somerville
, NJ 08876-0151 |
(908)
218
-2005
|
|
Device Event Key | 247659 |
MDR Report Key | 255764 |
Event Key | 239715 |
Report Number | 2210968-1999-00588 |
Device Sequence Number | 1 |
Product Code | GAS |
Report Source |
Manufacturer
|
Source Type |
Consumer
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
11/12/1999 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 12/23/1999 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Device Age | unknown |
Event Location |
Unknown
|
Date Manufacturer Received | 11/12/1999 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|
|
|