FDA Adverse Event
Malfunction
Summary report: N
DAFILON BLUE 3/0 (2) 45CM DS30 (M)
MDR report key: 3880682
·
Received May 28, 2014
Report
- Report Number
- 2916714-2014-00396
- Event Type
- Malfunction
- Date Received
- May 28, 2014
- Date of Event
- April 1, 2014
- Report Date
- May 28, 2014
- Manufacturer
- B. BRAUN SURGICAL S.A.
- Product Code
- GAR
- PMA / PMN Number
- K990090
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION ON-GOING AT MANUFACTURING SITE.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). THREAD IS BREAKING DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314177 | DAFILON BLUE 3/0 (2) 45CM DS30 (M) | SUTURE | GAR | B. BRAUN SURGICAL S.A. | C0933422 | 112184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |