Brand Name | OXINIUM FEM HD 12/14 32MM +4 |
Type of Device | PRSTHSS,HP,SM-CNSTRND, MTL/CRMC/PLYMR,CEMENTEDORNON-POROUS,UNCEMENTED |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
MDR Report Key | 8136048 |
MDR Text Key | 129432397 |
Report Number | 1020279-2018-02696 |
Device Sequence Number | 1 |
Product Code |
LZO
|
UDI-Device Identifier | 03596010474223 |
UDI-Public | 03596010474223 |
Combination Product (y/n) | N |
PMA/PMN Number | K021673 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
01/23/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/05/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 71343204 |
Device Lot Number | 17HM20625 |
Date Manufacturer Received | 11/08/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|