Brand Name | INTELLIOX PLUS |
Type of Device | GAS CYLINDER REGULATOR |
Manufacturer (Section D) |
CEODEUX S.A. |
24 rue de diekirch |
lintgen, lu L-744 0 |
LU L-7440 |
|
Manufacturer (Section G) |
CEODEUX S.A. |
24 rue de diekirch |
|
lintgen, lu L-744 0 |
LU
L-7440
|
|
Manufacturer Contact |
ron
weber
|
259 n radnor chester road |
radnor, PA 19087
|
|
MDR Report Key | 15089015 |
MDR Text Key | 296464153 |
Report Number | 3003764448-2022-00001 |
Device Sequence Number | 1 |
Product Code |
CAN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
07/17/2022 |
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? |
Yes
|
Device Operator |
Health Professional
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/17/2022 |
Initial Date FDA Received | 07/22/2022 |
Date Device Manufactured | 05/17/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
|
|