Type of Device | LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED |
Manufacturer (Section D) |
STERILMED, INC. |
11400 73rd ave n |
maple grove MN |
|
Manufacturer Contact |
jason
anderson
|
5010 cheshire parkway |
suite 2 |
plymouth, MN 55446
|
7634888348
|
|
MDR Report Key | 5915975 |
MDR Text Key | 53552161 |
Report Number | 2134070-2016-00065 |
Device Sequence Number | 1 |
Product Code |
NLM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K043592 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
08/08/2016 |
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 | ETH2B5LT |
Device Catalogue Number | ETH2B5LT |
Device Lot Number | 191834 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/08/2016
|
Initial Date FDA Received | 08/30/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 39 YR |
|
|