Brand Name | SET MENISCUS MENDER II DISPOSABLE |
Type of Device | PASSER |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
130 forbes blvd. |
mansfield MA 02048 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
130 forbes blvd. |
|
mansfield MA 02048 |
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 10138035 |
MDR Text Key | 194631956 |
Report Number | 1219602-2020-00875 |
Device Sequence Number | 1 |
Product Code |
HWQ
|
Combination Product (y/n) | N |
Reporter Country Code | HK |
PMA/PMN Number | K885311 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
08/06/2020 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 06/10/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Catalogue Number | 7209485 |
Device Lot Number | 2037273 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/09/2020 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 08/04/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/22/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|