FDA Adverse Event
Other
Summary report: N
KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER
MDR report key: 1514584
·
Received October 21, 2009
Report
- Report Number
- 9617494-2009-00006
- Event Type
- Other
- Date Received
- October 21, 2009
- Report Date
- October 21, 2009
- Manufacturer
- GMS-GESELLSCHAFT FUR MEDIZINISHE
- Product Code
- HGM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
A LICOX PMO IP2P.CC1.P1 FELL OUT OF A IP2P BOLT. THE INCIDENT OCCURRED WHEN THE PATIENT WAS BEING TURNED, SEVERAL DAYS AFTER THE KIT HAD BEEN INSERTED. THERE WAS NO KNOWN INJURY TO THE PATIENT FROM THIS INCIDENT. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER | NA | HGM | GMS-GESELLSCHAFT FUR MEDIZINISHE | 110908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |