Brand Name | MAGNESIUM |
Type of Device | PHOTOMETRIC METHOD, MAGNESIUM |
Manufacturer (Section D) |
A.I.D.D LONGFORD |
lisnamuck |
co. longford |
longford N39E9 32 |
EI N39E932 |
|
MDR Report Key | 12342291 |
MDR Text Key | 267264814 |
Report Number | 3005094123-2021-00153 |
Device Sequence Number | 1 |
Product Code |
JGJ
|
UDI-Device Identifier | 00380740169855 |
UDI-Public | 00380740169855 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Type of Report
| Initial,Followup |
Report Date |
08/31/2021 |
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 Expiration Date | 01/03/2022 |
Device Catalogue Number | 03P68-24 |
Device Lot Number | 26080UD00 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/27/2021
|
Initial Date FDA Received | 08/19/2021 |
Supplement Dates Manufacturer Received | 08/30/2021
|
Supplement Dates FDA Received | 08/31/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | ARC C16K PRC MOD, 03L77-01, C1600722; ARC C16K PRC MOD, 03L77-01, C1600722; ARC C16K PRC MOD, 03L77-01, C1600722 |
|
|