FDA Adverse Event
Malfunction
Summary report: N
NOVOSYN VIOLET 3/0 (2) 3X45CM
MDR report key: 3880621
·
Received May 28, 2014
Report
- Report Number
- 2916714-2014-00406
- Event Type
- Malfunction
- Date Received
- May 28, 2014
- Date of Event
- April 24, 2014
- Report Date
- May 28, 2014
- Manufacturer
- B. BRAUN SURGICAL S.A.
- Product Code
- GAM
- PMA / PMN Number
- K122734
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
US REPORTING AGENT NOTIFIED ON (B)(6) 2014. MFG SITE EVAL: EVAL ON-GOING.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). INNER FOIL WAS WELDED WITH OUTER FOIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313870 | NOVOSYN VIOLET 3/0 (2) 3X45CM | SYNTHETIC ABSORBABLE SUTURE | GAM | B. BRAUN SURGICAL S.A. | C0058625 | 114124V004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |