FDA Adverse Event
Other
Summary report: N
ALM
MDR report key: 843653
·
Received October 13, 2006
Report
- Report Number
- 3019090-2006-00002
- Event Type
- Other
- Date Received
- October 13, 2006
- Report Date
- September 8, 2006
- Manufacturer
- GETINGE USA, INC(F.K.A ALM SURGICAL EQUIP.(CA))
- Product Code
- FTD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LIGHT WAS REMOVED FROM SERVICE AND CUSTOMER WAS SUPPLIED WITH PORTABLE LIGHTS WHILE AN EVALUATION OF THE UNIT IS BEING PERFORMED. CUSTOMER WILL BE PROVIDED WITH A QUOTE TO REPAIR THE LIGHTHEADS AND A QUOTE TO PURCHASE NEW LIGHTHEADS.
Description of Event or Problem · 1
WHILE REMOVING THE AX-4 LIGHT FROM ITS ENCLOSURE DURING A PROCEDURE THE BACK COVER FELL OFF AND HIT PATIENT'S HUSBAND IN THE HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALM | SURGICAL LIGHT | FTD | GETINGE USA, INC(F.K.A ALM SURGICAL EQUIP.(CA)) | LDR AX-4 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |