FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I
MDR report key: 1191897
·
Received September 30, 2008
Report
- Report Number
- 2024601-2008-00753
- Event Type
- Malfunction
- Date Received
- September 30, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 5, 2008
- Manufacturer
- COSTA RICA
- Product Code
- LTI
- PMA / PMN Number
- P000008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TAPER TYPE II. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. THE REPORTER OF THE EVENT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. VISUAL EXAMINATION MAY CONFIRM OR DETERMINE ANOTHER CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. 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."
Description of Event or Problem · 1
REPORTED AS A LEAK IN THE PORT TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM ACCESS PORT I | DEVICE FOR TREATMENT OF MORBID OBESITY | LTI | COSTA RICA | NA | 1231385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |