D
Patient 1
HEALTHCARE PROFESSIONAL REPORTEDLY FOUND PORT WAS DISCONNECTED DURING SCREENING "THE DISTIL LENGTH HAD DROPPED BACK INSIDE" AND THE PHYSICIAN "LAPAROSCOPED AND FOUND THE TUBING AND RECONNECTED IT USING THE ORIGINAL CONNECTOR."
MAUDE MDR 4834614
- MDR report key
- 4834614
- Report number
- 3006722112-2015-00093
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-05-12
- Date received
- 2015-06-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURA LEBEOUF
- Address
- 1120 S CAPITAL OF TX HWY BLDG 1, STE 300 AUSTIN TX 78748 US
- Phone
- 855-855-8555
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-08 | 0 |
Event Narratives#
N
Patient 1
TAPER UNKNOWN. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT MODEL NUMBER, SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGAN. THE CONNECTOR TYPE CANNOT BE IDENTIFIED NOR AN ASSUMPTION BE MADE AS TO THE TYPE OF CONNECTOR ASSOCIATED WITH THIS COMPLAINT BECAUSE NO MODEL NUMBER, SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. 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 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."