Brand Name | SHARPSAFETY |
Type of Device | CONTAINER, SHARPS |
Manufacturer (Section D) |
COV LP/LLC, CRYSTAL LAKE, MFG |
815 tek dr |
crystal lake IL 60014 8172 |
|
Manufacturer (Section G) |
COV LP/LLC, CRYSTAL LAKE, MFG |
815 tek dr |
|
crystal lake IL 60014 8172 |
|
Manufacturer Contact |
edward almeida
|
15 hampshire street |
mansfield, MA 02048
|
5084524151
|
|
MDR Report Key | 6762011 |
MDR Text Key | 81673564 |
Report Number | 1424643-2017-05015 |
Device Sequence Number | 1 |
Product Code |
MMK
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/06/2017 |
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 Model Number | 89651 |
Device Catalogue Number | 89651 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/06/2017
|
Initial Date FDA Received | 08/02/2017 |
Supplement Dates Manufacturer Received | 07/06/2017
|
Supplement Dates FDA Received | 08/28/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|