D
Patient 1
PHYSICIAN REPORTED A DEVICE'S ORIGINAL PORT HAD BEEN EXPLANTED AND REPLACED. THIS WAS DUE TO A PORT LEAK AT THE BASE PLATE.
MAUDE MDR 4717953
- MDR report key
- 4717953
- Report number
- 3006722112-2015-00007
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-02-03
- Date received
- 2015-04-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURAL LEBOEUF
- 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 | 2015-04-20 | 0 |
Event Narratives#
N
Patient 1
(B)(4). TAPER II. THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AND WAS DISCARDED AFTER SURGERY BY THE REPORTER. BASED UPON THE SERIAL NUMBER AND EXPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN WILL NOT RECEIVE THE PORT AND NO ANALYSIS OR TESTING WILL BE DONE. NO ADDITIONAL INFO HAS BEEN REPORTED TO ALLERGAN REGARDING THE EVENT DATE, IMPLANT DATE, DIAGNOSTIC TESTING, PT DATA 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".