Brand Name | MEMBER'S MARK |
Type of Device | INSULIN SYRINGE |
Manufacturer (Section D) |
MHC MEDICAL PRODUCTS, LLC. |
8695 seward rd. |
fairfield, oh OH 45011 |
|
MDR Report Key | 9665346 |
MDR Text Key | 178019186 |
Report Number | 3005798905-2020-02907 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
PMA/PMN Number | K102178 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Remedial Action |
Replace |
Type of Report
| Initial,Followup |
Report Date |
01/27/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/04/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 730365 |
Device Lot Number | 45322 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/23/2020 |
Date Manufacturer Received | 01/13/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|