Brand Name | R3 PRIMARY LINERS XL |
Type of Device | R3 20 DEG XLPE LNR 40MM ID X 56OD |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
1450 brooks road |
|
memphis TN 38116 |
|
Manufacturer Contact |
lisa
hassell
|
1450 brooks road |
memphis, TN 38116
|
9013991128
|
|
MDR Report Key | 4069815 |
MDR Text Key | 18546220 |
Report Number | 1020279-2014-00546 |
Device Sequence Number | 1 |
Product Code |
JDH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/07/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/08/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/01/2020 |
Device Catalogue Number | 71338687 |
Device Lot Number | 10AM07701 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/26/2014 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 09/04/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/01/2010 |
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 |
Treatment | 71342340/12DM00579; 71344249/11BT03334 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 57 YR |