FDA Adverse Event
Malfunction
Summary report: N
STEELEX STE SET 6 (8) 4X45CM HRS48
MDR report key: 3695106
·
Received February 7, 2014
Report
- Report Number
- 2916714-2014-00086
- Event Type
- Malfunction
- Date Received
- February 7, 2014
- Report Date
- February 3, 2014
- Manufacturer
- B. BRAUN SURGICAL S.A.
- Product Code
- GAQ
- PMA / PMN Number
- K023411
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING, RESULTS NOT YET AVAILABLE.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). LABEL (OUTSIDE) AND PACKAGE (INSIDE) DO NOT MATCH. LABEL OF OUTSIDE BOX SHOWS STERNUM SET USP 6 (G0617814;BATCH 113065) BUT INSIDE THE BOX THERE IS STERNUM SET USP 7 (G0617804, BATCH 112514).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79314 | STEELEX STE SET 6 (8) 4X45CM HRS48 | GAQ | GAQ | B. BRAUN SURGICAL S.A. | G0617814 | 113065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |