FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM ACCESS PORT I
MDR report key: 1203374
·
Received October 14, 2008
Report
- Report Number
- 2024601-2008-00792
- Event Type
- Malfunction
- Date Received
- October 14, 2008
- Date of Event
- June 15, 2008
- Report Date
- September 19, 2008
- Manufacturer
- COSTA RICA
- Product Code
- LTI
- PMA / PMN Number
- P000008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
TAPER TYPE II. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AS IT WAS NOT EXPLANTED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. 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 BY THE PATIENT AS: "A LEAK, I'VE HAD MANY FILLS WITH NO RESTRICTION, THEY CAN'T FIND THE SOURCE OF THE LEAKING. IT WAS DIAGNOSED UNDER FLUOROSCOPY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM ACCESS PORT I | DEVICE FOR TREATMENT OF MORBID OBESITY | LTI | COSTA RICA | NA | 1270549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |