FDA Adverse Event
Malfunction
Summary report: N
MONOPLUS C VIOLET 2/0 (3) 25M
MDR report key: 3982733
·
Received June 16, 2014
Report
- Report Number
- 2916716-2014-00450
- Event Type
- Malfunction
- Date Received
- June 16, 2014
- Date of Event
- April 10, 2014
- Report Date
- June 14, 2014
- Manufacturer
- B. BRAUN SURGICAL S.A.
- Product Code
- GAM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
US REPORTING AGENT NOTIFIED ON (B)(4) 2014.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). THREAD BREAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353477 | MONOPLUS C VIOLET 2/0 (3) 25M | SYNTHETIC ABSORBABLE SUTURE | GAM | B. BRAUN SURGICAL S.A. | F0024272 | 113441 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |