FDA Adverse Event
Malfunction
Summary report: N
PREMILENE 6/0 (0,7) 45CM DS12 (M) POW
MDR report key: 5634296
·
Received May 5, 2016
Report
- Report Number
- 2916714-2016-00340
- Event Type
- Malfunction
- Date Received
- May 5, 2016
- Date of Event
- February 17, 2016
- Report Date
- May 5, 2016
- Manufacturer
- B.BRAUN SURGICAL SA
- Product Code
- GAW
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE REGISTERED WITHIN THE U.S. (B)(4) (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: COLOMBIA. THE SUTURE PREMILENE USED IN SURGERY, THE NEEDLE LOST THE EDGE OVER THE FIRST POINT AND OTHERS UNTIED; THE THREAD IS SCREWED PASSING POINTS. PROLENE 5/0 BY ETHICON IT CHANGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288641 | PREMILENE 6/0 (0,7) 45CM DS12 (M) POW | SUTURES | GAW | B.BRAUN SURGICAL SA | C0095278 | 515063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |