FDA Adverse Event
Malfunction
Summary report: N
30348 30805 DELUXE JACKSON KIT
MDR report key: 1121985
·
Received August 13, 2008
Report
- Report Number
- 1282497-2008-00024
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- March 24, 2008
- Report Date
- July 18, 2008
- Manufacturer
- ANATOMIC CONCEPTS
- Product Code
- CCX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION. THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH A SOFT TOUCH POSITIONER. THE CUSTOMER REPORTS THAT A PATIENT DEVELOPED A FACIAL WOUND WHILE LYING ON THE SOFT TOUCH POSITIONER WHICH IS PACKAGED IN THE DELUXE JACKSON KIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 30348 30805 DELUXE JACKSON KIT | SOFT TOUCH POSITIONER | CCX | ANATOMIC CONCEPTS | 50001027 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |