FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 998563
·
Received January 30, 2008
Report
- Report Number
- 998563
- Event Type
- Malfunction
- Date Received
- January 30, 2008
- Date of Event
- January 7, 2008
- Report Date
- January 30, 2008
- Manufacturer
- APPLIED MEDICAL RESOURCES CORPORATION
- Product Code
- NLX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
UPON INSPECTION, IT WAS FOUND THAT THE INSUFFLATION NEEDLE TIP BENT AND OCCLUDED THE FLOW OF CO2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | NEEDLE, INSUFFLATION | NLX | APPLIED MEDICAL RESOURCES CORPORATION | REF #: C2201 | 1039649 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |