Brand Name | ACCESS |
Type of Device | SYSTEM, IRRIGATION, UROLOGICAL |
Manufacturer (Section D) |
BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS |
route de chebbaou |
oued elil 2021 tn |
tunis |
TS |
|
Manufacturer (Section G) |
BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS |
route de chebbaou |
oued elil 2021 tn |
tunis |
TS
|
|
Manufacturer Contact |
kinga
almasan
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 4609348 |
MDR Text Key | 5659769 |
Report Number | 1416980-2015-11407 |
Device Sequence Number | 1 |
Product Code |
LJH
|
Combination Product (y/n) | N |
Reporter Country Code | SW |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/18/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/17/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 03/31/2019 |
Device Catalogue Number | VMC4005 |
Device Lot Number | 14D30V030 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/11/2015 |
Date Manufacturer Received | 02/18/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/17/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |