FDA Adverse Event
Malfunction
Summary report: N
MONOMAX VIOLET 1(4)150CM HRT40S LOOPM
MDR report key: 7029039
·
Received November 14, 2017
Report
- Report Number
- 3003639970-2017-00551
- Event Type
- Malfunction
- Date Received
- November 14, 2017
- Report Date
- November 14, 2017
- Manufacturer
- B.BRAUN SURGICAL SA
- Product Code
- NWJ
- PMA / PMN Number
- K100876
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING H3 OTHER TEXT : DEVICE NOT RETURNED
Description of Event or Problem · 0
COUNTRY OF COMPLAINT: FRANCE. IT WAS REPORTED THAT TWO (2) PATIENTS WITH ABDOMINAL WALL INFECTIONS WITH MONOMAX. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 3003639970-2017-00551, 3003639970-2017-00566.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 809936 | MONOMAX VIOLET 1(4)150CM HRT40S LOOPM | SUTURES | NWJ | B.BRAUN SURGICAL SA | B0041185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |