Brand Name | INPEN |
Type of Device | INPEN |
Manufacturer (Section D) |
COMPANION MEDICAL INC |
1223 world trade drive, 100 |
san diego CA 92128 |
|
Manufacturer (Section G) |
COMPANION MEDICAL INC |
1223 world trade drive, 100 |
|
san diego CA 92128 |
|
Manufacturer Contact |
neal
grant
|
1223 world trade drive, 100 |
san diego, CA 92128
|
|
MDR Report Key | 10864800 |
MDR Text Key | 218983155 |
Report Number | 3012822846-2020-00105 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Type of Report
| Initial |
Report Date |
11/18/2020 |
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 |
Lay User/Patient
|
Device Model Number | MMT-XXX |
Device Catalogue Number | MMT-XXX |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/16/2020 |
Initial Date FDA Received | 11/18/2020 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 31 YR |
Patient Weight | 73 |
|
|