FDA Adverse Event
Malfunction
Summary report: N
2024601-2008-00006
MDR report key: 1121208
·
Received January 3, 2008
Report
- Report Number
- 2024601-2008-00006
- Event Type
- Malfunction
- Date Received
- January 3, 2008
- Product Code
- LTI
- PMA / PMN Number
- P000008
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER OF THE DEVICE AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LTI | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |