Type of Device | CLIP, IMPLANTABLE, REPROCESSED |
Manufacturer (Section D) |
STERILMED, INC. |
5010 cheshire pkwy n ste 2 |
plymouth MN 55446 |
|
MDR Report Key | 8045438 |
MDR Text Key | 126397332 |
Report Number | 8045438 |
Device Sequence Number | 1 |
Product Code |
NMJ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
11/01/2018 |
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 Catalogue Number | ER320 |
Device Lot Number | 2033856 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/01/2018 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/07/2018 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 11/07/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 25915 DA |
Patient Weight | 120 |
|
|