Brand Name | HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK |
Type of Device | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
mansfield MA 02048 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
|
mansfield MA 02048 |
|
Manufacturer Contact |
james
gonzales
|
7000 west william cannon drive |
austin, TX 78735
|
5123585706
|
|
MDR Report Key | 5810270 |
MDR Text Key | 50071943 |
Report Number | 1219602-2016-00414 |
Device Sequence Number | 1 |
Product Code |
MBI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K151105 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,other |
Reporter Occupation |
Patient
|
Type of Report
| Initial,Followup |
Report Date |
06/23/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2017 |
Device Catalogue Number | 72203707 |
Device Lot Number | 50497599 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/23/2016
|
Initial Date FDA Received | 07/20/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/13/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/20/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|