FDA Adverse Event
Malfunction
Summary report: N
SAFE-T-PRO PLUS
MDR report key: 2020291
·
Received March 16, 2011
Report
- Report Number
- 1823260-2011-01429
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 14, 2011
- Report Date
- May 6, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FMK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CALLER STATES THE CLEANER AT A MEDICAL PRACTICE FACILITY PRICKED HERSELF ON A SAFE-T PRO PLUS DEVICE THAT DID NOT HAVE THE STERILITY CAP ON IT. NO MEDICAL TREATMENT REQUIRED. CALLER ALSO REPORTED FINDING SEVERAL SAFE-T-PRO PLUS DEVICES DISASSEMBLED IN THE BOX. REQUESTED RETURN OF SUSPECT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAFE-T-PRO PLUS | LANCET | FMK | ROCHE DIAGNOSTICS | NA | R211006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |