Brand Name | MEDISORB¿ PRE-PACKED ROUNDS, DISPOSABLE |
Type of Device | ABSORBENT, CARBON-DIOXIDE |
Manufacturer (Section D) |
VYAIRE MEDICAL OY |
kuortaneenkatu 2 helsinki ete |
la-suomen laani |
helsinki |
FI |
|
Manufacturer (Section G) |
MOLECULAR PRODUCTS LTD |
parkway harlow business park |
|
harlow, essex CM19 5FR |
UK
CM19 5FR
|
|
Manufacturer Contact |
sandra
valencia
|
510 technology drive |
irvine, CA 92618
|
2402760001
|
|
MDR Report Key | 18735881 |
MDR Text Key | 336760063 |
Report Number | 3010838917-2024-00106 |
Device Sequence Number | 1 |
Product Code |
CBL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/19/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | MEDISORB PREPACKED CARTRIDGE |
Device Catalogue Number | 427000100 |
Device Lot Number | NOT PROVIDED |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/25/2024
|
Initial Date FDA Received | 02/19/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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 |