FDA Adverse Event
Malfunction
Summary report: N
AL-III W/ MALE DISCONNECT AND 20 FT HOSE
MDR report key: 3000175
·
Received February 14, 2013
Report
- Report Number
- 1045834-2013-00230
- Event Type
- Malfunction
- Date Received
- February 14, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 16, 2013
- Manufacturer
- THE ANSPACH EFFORT, INC.
- Product Code
- GEY
- PMA / PMN Number
- K970530
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY INSPACH. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THE DEVICE WAS "LEAKING OIL FROM THE FILTER HOUSING" DURING ROUTINE INSPECTION. THE DEVICE WAS NOT USED IN SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65358 | AL-III W/ MALE DISCONNECT AND 20 FT HOSE | GEY | THE ANSPACH EFFORT, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |