Brand Name | UNIVERSAL LIGHT GUIDE ORANGE 4MM X 12 FT |
Type of Device | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
150 minuteman road |
andover MA 01810 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
150 minuteman road |
|
andover MA 01810 |
|
Manufacturer Contact |
jim
gonzales
|
7000 west william cannon drive |
austin, TX 78735
|
5123585706
|
|
MDR Report Key | 7763581 |
MDR Text Key | 116860866 |
Report Number | 3003604053-2018-00126 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
UDI-Device Identifier | 00885556643716 |
UDI-Public | (01)00885556643716(10)134379 |
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | K914919 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
08/04/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/08/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 72204922 |
Device Catalogue Number | 72204922 |
Device Lot Number | 134379 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/11/2018 |
Date Manufacturer Received | 09/19/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/31/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |