Brand Name | FAST FIX 360 CURVED NEEDLE DELIVERY SYSTEM |
Type of Device | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
Manufacturer (Section D) |
SMITH & NEPHEW, INC., ENDOSCOPY DIVISION |
andover MA 01810 |
|
MDR Report Key | 8046015 |
MDR Text Key | 126638532 |
Report Number | MW5081106 |
Device Sequence Number | 1 |
Product Code |
MBI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
11/01/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/05/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/10/2021 |
Device Catalogue Number | 72202468 |
Device Lot Number | 50706962 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 18 YR |
Patient Weight | 79 |
|
|