D
Patient 1
REPORTED BY THE PT AS A PORT LEAK.
MAUDE MDR 1056858
- MDR report key
- 1056858
- Report number
- 2024601-2008-00295
- Event key
- 0
- Event type
- 3
- Date of event
- 2004-10-15
- Date received
- 2008-06-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. LAURA LEBOEUF
- Address
- 1120 S CAPITAL OF TEXAS HWY BULDING 1, SUITE 300 AUSTIN TX 78748 US
- Phone
- 855-855-8555
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG | DEVICE FOR TREATMENT OF MORBID OBESITY | COSTA RICA | LTI | NA | NI | NI | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-06-02 | 0 | 1. H; 2. O; 3. R |
Event Narratives#
N
Patient 1
TAPER II. THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE IMPLANT DATE AND DEVICE MODEL TYPE 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. FURTHER INFO FROM THE REPORTER REGARDING SERIAL NUMBER HAS BEEN REQUESTED. 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."
N
Patient 1
INFECTION IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF AN INFECTION AS FOLLOWS: "INFECTION CAN OCCUR IN THE IMMEDIATE POST-OPERATIVE PERIOD OR YEARS AFTER INSERTION OF THE DEVICE. IN THE PRESENCE OF INFECTION OR CONTAMINATION, REMOVAL OF THE DEVICE IS INDICATED."
D
Patient 1
ADDITIONAL INFORMATION: PATIENT REPORTED THE REASON FOR REMOVAL WAS DUE TO LEAK AND "INFECTION".
N
Patient 1
FOLLOW UP FINDINGS DETERMINED INFORMATION CONTAINED IN MEDWATCH REPORT 2024601-2008-00296 ARE RELEVANT TO THIS REPORT, 2024601-2008-00295. ALL INFORMATION CONTAINED IN INITIAL RECORD 2024601-2008-00296 AND SUPPLEMENTAL RECORDS 1 THROUGH 4 SHOULD BE CONTAINED IN THIS REPORT.
D
Patient 1
ADDITIONAL INFORMATION: PATIENT REPORTED THE FIRST PROCEDURE WAS A PORT ONLY REPLACEMENT AND THE ORIGINAL BAND REMAINS IMPLANTED, ALSO REPORTED "VOCAL CHANGES, SOUNDS MANLY".