Brand Name | EASYTOUCH |
Type of Device | SAFETY 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 | 15478275 |
MDR Text Key | 306360410 |
Report Number | 3005798905-2022-03079 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130212 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
09/23/2022 |
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 | 08/09/2022 |
Device Catalogue Number | 802024 |
Device Lot Number | 54313 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/29/2022 |
Initial Date FDA Received | 09/24/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|