Brand Name | MEMBER'S MARK |
Type of Device | INSULIN SYRINGE |
Manufacturer (Section D) |
MHC MEDICAL PRODUCTS, LLC |
8695 seward road |
fairfield OH 45011 |
|
Manufacturer (Section G) |
MHC MEDICAL PRODUCTS, LLC |
8695 seward road |
|
fairfield OH 45011 |
|
Manufacturer Contact |
troy
smith
|
8695 seward road |
fairfield, OH 45011
|
|
MDR Report Key | 10744114 |
MDR Text Key | 213679030 |
Report Number | 3005798905-2020-02969 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K102178 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
10/27/2020 |
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 Catalogue Number | 730165 |
Device Lot Number | 50441 |
Initial Date Manufacturer Received |
09/24/2020 |
Initial Date FDA Received | 10/27/2020 |
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 |
|
|