Brand Name | SAFIL VIOLET 2/3 (3) 90CM HR372 (M) |
Type of Device | SYTHETIC ABSORBABLE SUTURE |
Manufacturer (Section D) |
B. BRAUN SURGICAL S.A. |
rubi (barcelona) 0819 1 |
SP 08191 |
|
Manufacturer (Section G) |
B. BRAUN SURGICAL SA |
121 carretera de terrassa |
|
rubi (barcelona) 0819 1 |
SP
08191
|
|
Manufacturer Contact |
michelle
link
|
615 lambert pointe drive |
hazelwood, MO 63042
|
3145515938
|
|
MDR Report Key | 3877203 |
MDR Text Key | 20701827 |
Report Number | 2916714-2014-00359 |
Device Sequence Number | 1 |
Product Code |
GAM
|
Combination Product (y/n) | N |
Reporter Country Code | CO |
PMA/PMN Number | K031286 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
05/19/2014 |
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 Model Number | C1048595 |
Device Catalogue Number | C1048595 |
Device Lot Number | 113362 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/22/2014
|
Initial Date FDA Received | 05/19/2014 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
Patient Outcome(s) |
Other;
|