Brand Name | FL23SE |
Type of Device | MEDICAL BED |
Manufacturer (Section D) |
UMANO MEDICAL INC |
230 boulevard nilus-leclerc |
l'islet, quebec G0R 2 C0 |
CA G0R 2C0 |
|
Manufacturer (Section G) |
UMANO MEDICAL INC |
230 boulevard nilus-leclerc |
|
l'islet, quebec G0R 2 C0 |
CA
G0R 2C0
|
|
Manufacturer Contact |
maude
thibault
|
230 boulevard nilus-leclerc |
l'islet, quebec
|
CA
|
|
MDR Report Key | 8434213 |
MDR Text Key | 139257495 |
Report Number | 3009591865-2019-00008 |
Device Sequence Number | 1 |
Product Code |
FNL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,user faci |
Reporter Occupation |
Other
|
Remedial Action |
Inspection |
Type of Report
| Initial |
Report Date |
03/19/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/19/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | FL23SE |
Device Catalogue Number | FL23SE |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 02/19/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/07/2015 |
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 |
|
|