Brand Name | NOVOSYN UNDYED 3/0 (2)45CM DSMP19 (M)RCP |
Type of Device | SYNTHETIC ABSORBABLE BRAIDED SUTURE |
Manufacturer (Section D) |
B. BRAUN SURGICAL, S.A. |
carretera de terrassa 121 |
rubí, barcelona 08191 |
SP 08191 |
|
Manufacturer (Section G) |
B. BRAUN SURGICAL, S.A. |
carretera de terrassa 121 |
|
rubí, barcelona 08191 |
SP
08191
|
|
Manufacturer Contact |
martina
laporte
|
carretera de terrassa 121 |
rubí, barcelona 08191
|
SP
08191
|
|
MDR Report Key | 18986604 |
MDR Text Key | 338760015 |
Report Number | 3003639970-2024-00100 |
Device Sequence Number | 1 |
Product Code |
GAM
|
Combination Product (y/n) | N |
Reporter Country Code | NL |
PMA/PMN Number | K122734 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/27/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/27/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | C0069630N1 |
Device Catalogue Number | C0069630N1 |
Device Lot Number | 33391A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/01/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 09/29/2023 |
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 Sex | Prefer Not To Disclose |