Brand Name | GYNECARE UNKNOWN PRODUCT |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 |
|
Manufacturer (Section G) |
ETHICON INC.-SAN LORENZO PR |
982 road 183 km 8.3 |
|
san lorenzo PR |
*
|
|
Manufacturer Contact |
elba
bello
|
p.o. box 151, route 22 west |
somerville, NJ 08876
|
9082183429
|
|
MDR Report Key | 10244832 |
MDR Text Key | 198106615 |
Report Number | 2210968-2020-05083 |
Device Sequence Number | 1 |
Product Code |
OTO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K013718 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/06/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/06/2020 |
Initial Date FDA Received | 07/08/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 34 YR |
|
|