Brand Name | NA |
Type of Device | LAPAROSCOPE, REPROCESSED |
Manufacturer (Section D) |
STERILMED, INC. |
maple grove MN |
|
Manufacturer Contact |
tricia
shrater
|
11400 73rd ave. north |
maple grove, MN 55369
|
7634883211
|
|
MDR Report Key | 4188065 |
MDR Text Key | 5027443 |
Report Number | 2134070-2014-00179 |
Device Sequence Number | 1 |
Product Code |
NLM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K111002 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/22/2014 |
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 | 07/01/2015 |
Device Model Number | APPCOR37 |
Device Catalogue Number | COR37 |
Device Lot Number | 1789001 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 09/23/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/22/2014
|
Initial Date FDA Received | 10/17/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/01/2014 |
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 |
|
|