Brand Name | ULTRAPRO MESH UNKNOWN PRODUCT |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 |
|
Manufacturer (Section G) |
ETHICON INC.-GMBH |
robert-koch strasse 1 |
|
norderstedt 22851 |
GM
22851
|
|
Manufacturer Contact |
kara
ditty-bovard
|
p.o. box 151, route 22 west |
somerville, NJ 08876
|
6107428552
|
|
MDR Report Key | 9948379 |
MDR Text Key | 187229542 |
Report Number | 2210968-2020-02889 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K033337 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/26/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | ULTRAPROMUNK |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/26/2020 |
Initial Date FDA Received | 04/10/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|