Brand Name | CANNULA THREADED FLEX 6.5 X 72MM |
Type of Device | ACCESSORIES,ARTHROSCOPIC |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
mansfield MA 02048 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
|
mansfield MA 02048 |
|
Manufacturer Contact |
jim
gonzales
|
7000 west william cannon drive |
austin, TX 78735
|
|
MDR Report Key | 7410092 |
MDR Text Key | 105172275 |
Report Number | 1219602-2018-00424 |
Device Sequence Number | 1 |
Product Code |
NBH
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/04/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 72200427 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/23/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/13/2018
|
Initial Date FDA Received | 04/09/2018 |
Supplement Dates Manufacturer Received | 06/04/2018
|
Supplement Dates FDA Received | 06/04/2018
|
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 |
|
|