Brand Name | STEELEX ELEC 3/0 (2) 60CM HRT26/GS65 |
Type of Device | SUTURES |
Manufacturer (Section D) |
B.BRAUN SURGICAL SA |
121 carretera de terrassa |
rubi, barcelona 08191 |
SP 08191 |
|
Manufacturer (Section G) |
B.BRAUN SURGICAL SA |
121 carretera de terrassa |
|
rubi, barcelona 08191 |
SP
08191
|
|
Manufacturer Contact |
nicole
broyles
|
615 lambert pointe drive |
hazelwood, MO 63042
|
3145515988
|
|
MDR Report Key | 5814385 |
MDR Text Key | 51062259 |
Report Number | 2916714-2016-00606 |
Device Sequence Number | 1 |
Product Code |
LDF
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K030556 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/20/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/21/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | C0992070 |
Device Catalogue Number | C0992070 |
Was Device Available for Evaluation? |
No
|
Distributor Facility Aware Date | 07/15/2016 |
Date Manufacturer Received | 06/21/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|