Type of Device | FORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED |
Manufacturer (Section D) |
STERILMED, INC. |
11400 73rd ave n |
maple grv MN |
|
Manufacturer Contact |
|
11400 73rd ave n |
maple grv, MN 55369
|
|
MDR Report Key | 4729212 |
MDR Text Key | 5736970 |
Report Number | 2134070-2015-00018 |
Device Sequence Number | 1 |
Product Code |
NON
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K042648 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Invalid Data |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/25/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/25/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Device Expiration Date | 02/29/2016 |
Device Catalogue Number | MIC1337 |
Device Lot Number | 1842880 |
Date Device Manufactured | 02/19/2015 |
Patient Sequence Number | 1 |
Patient Age | 67 YR |
Patient Weight | 423 |
|
|