Brand Name | VERSAFITCUP DM 01.26.2850M DOUBLE MOBILITY LINER Ø 50/28 |
Type of Device | DOUBLE MOBILITY LINER |
Manufacturer (Section D) |
MEDACTA INTERNATIONAL SA |
strada regina |
castel san pietro, 6874 |
SZ 6874 |
|
Manufacturer (Section G) |
MEDACTA INTERNATIONAL SA |
strada regina |
|
castel san pietro, 6874 |
SZ
6874
|
|
Manufacturer Contact |
stefano
baj
|
strada regina |
castel san pietro, switzerland 6874
|
SZ
6874
|
|
MDR Report Key | 13078037 |
MDR Text Key | 283395121 |
Report Number | 3005180920-2021-01022 |
Device Sequence Number | 1 |
Product Code |
MEH
|
UDI-Device Identifier | 07630030807275 |
UDI-Public | 07630030807275 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K083116 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/23/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2014 |
Device Model Number | 01.26.2850M |
Device Catalogue Number | 01.26.2850M |
Device Lot Number | 090898 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/06/2021 |
Initial Date FDA Received | 12/23/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/04/2009 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |
|
|