FDA Adverse Event
Malfunction
Summary report: N
SLINGS, CLIP
MDR report key: 3121721
·
Received May 9, 2013
Report
- Report Number
- 1419652-2013-00013
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 9, 2013
- Report Date
- April 10, 2013
- Manufacturer
- ARJO HOSP EQUIPMENT AB
- Product Code
- FNG
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCORDING TO THE CUSTOMER'S DESCRIPTION: "THE TAILOR MADE SLING WAS FOUND TO HAVE A PIN SEWN INTO IT AND IT POKED A RESIDENT CAUSING A 1.5 INCH SCRATCH." REF #9611530-2013-00043.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203970 | SLINGS, CLIP | SLING | FNG | ARJO HOSP EQUIPMENT AB | MAA4050-M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |