FDA Adverse Event
Other
Summary report: N
MAQUET SA
MDR report key: 863699
·
Received September 26, 2006
Report
- Report Number
- 9710055-2006-00005
- Event Type
- Other
- Date Received
- September 26, 2006
- Report Date
- August 21, 2006
- Manufacturer
- MAQUET S.A.
- Product Code
- FTD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER DETERMINED THAT INCIDENT OCCURRED DUE TO LACK OF MAINTENANCE ON THE UNIT. MAINTENANCE INFORMATION FOR THE UNIT PROVIDED IN THE USER'S MANUAL ADVISES THAT THE CONDITION OF ALL PAINTED PARTS, ESPECIALLY THOSE WHO ARE SUBECT TO IMPACT FROM OTHER EQUIPMENT SHOULD BE CHECKED PERIODICALLY. INFORMATION ON THE AVAILABILITY OF TOUCH UP PAINT WAS PROVDED. GETTING USA, INC SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANFUACTURING FACILITY. MAQUET PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCIRBED IN THIS REPORT.
Description of Event or Problem · 1
PAINT CHIPS FROM SURGICAL LIGHT FELL INTO OPEN ORTHOPEDIC WOUND DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAQUET SA | SURGICAL LAMP | FTD | MAQUET S.A. | PRC | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |