Brand Name | MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILE |
Type of Device | LIGHT SHIELD |
Manufacturer (Section D) |
ASPEN SURGICAL PRODUCTS, CALEDONIA |
6945 southbelt dr. s.e. |
caledonia MI 49316 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
megan
morrissey
|
6945 southbelt dr. s.e. |
caledonia, MI 49316
|
|
MDR Report Key | 6957357 |
MDR Text Key | 90647070 |
Report Number | 1836161-2017-00111 |
Device Sequence Number | 1 |
Product Code |
FTA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K020304 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/18/2017 |
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 |
Other
|
Device Model Number | NB8001 |
Device Lot Number | 141757 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/18/2017 |
Initial Date FDA Received | 10/18/2017 |
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 |
Initial
|
Patient Sequence Number | 1 |
|
|