D
Patient 1
HEALTHCARE PROFESSIONAL REPORTED A LAP-BAND SYSTEM PORT WAS REMOVED AND REPLACED DUE TO A "LEAK."
MAUDE MDR 4745337
- MDR report key
- 4745337
- Report number
- 3006722112-2015-00019
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-04-02
- Date received
- 2015-04-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURA LEBOEUG
- Address
- 1120 S CAPITAL OF TEXAS HWY BLDG 1, STE 300 AUSTIN TX 78746 US
- Phone
- 855-855-8555
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-04-30 | 0 |
Event Narratives#
N
Patient 1
UNIQUE IDENTIFIER (UDI)#: NOT APPLICABLE. TAPER II. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON IMPLANT DATE AND EXPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DOWN. NO ADDITIONAL INFORMATION HAVE BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER, THE EVENT DATE, DIAGNOSTIC TESTING OR FURTHER EVENT DETAILS. 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
MEDWATCH SENT TO FDA ON: 05/27/2015. OBSTRUCTION, BAND SLIPPAGE, VOMITING AND UNSATISFACTORY WEIGHT LOSS ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.
D
Patient 1
FOLLOW UP FINDINGS: HEALTHCARE PROFESSIONAL REPORTED PATIENT UNDERWENT A PREVIOUS PORT REVISION SURGERY DUE TO "PORT TIPPED ON THE SIDE". PATIENT ALSO UNDERWENT REVISION SURGERIES PREVIOUSLY TO UNBUCKLE AND SUBSEQUENTLY RE-BUCKLE THE BAND DUE TO "VOMITING", "COULDN'T KEEP ANYTHING DOWN", "BAND SLIPPAGE" AND "OBSTRUCTION". HEALTHCARE PROFESSIONAL STATED PATIENT HAD "WEIGHT GAIN" AND "PORT APPEARED TO BE LOSING VOLUME".
N
Patient 1
TAPER II. MEDWATCH SENT TO FDA ON. 07/20/2015. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED THREE SMOOTH CURVED OPENINGS WITH LEAKAGE IN THE BAND TUBING CONSISTENT WITH WEAR AND TEAR. ANALYSIS NOTED THAT THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE.