Brand Name | SERVICE REP FOOTSWITCH EP-1 |
Type of Device | ARTHROSCOPE |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
76 s. meridian ave. |
oklahoma city OK 73107 6512 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
76 s. meridian ave. |
|
oklahoma city OK 73107 6512 |
|
Manufacturer Contact |
jim
gonzales
|
7000 west william cannon drive |
austin, TX 78735
|
|
MDR Report Key | 7303424 |
MDR Text Key | 101347550 |
Report Number | 1643264-2018-00177 |
Device Sequence Number | 1 |
Product Code |
HRX
|
UDI-Device Identifier | 03596010251978 |
UDI-Public | (01)03596010251978 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K892062 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/04/2018 |
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 Model Number | 7205396S |
Device Catalogue Number | 7205396S |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/17/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/23/2018 |
Initial Date FDA Received | 02/28/2018 |
Supplement Dates Manufacturer Received | 04/12/2018 04/12/2018
|
Supplement Dates FDA Received | 04/16/2018 05/04/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |