D
Patient 1
HEALTHCARE PROFESSIONAL REPORTED BAND SLIPPAGE.
MAUDE MDR 4959482
- MDR report key
- 4959482
- Report number
- 2024601-2014-00666
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-11-25
- Date received
- 2015-07-30
- 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 LEBOEUF
- Address
- 1120 S. CAPITAL OF TEXAS 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 | 2015-07-30 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE REPORTER OF THE COMPLAINT ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, IMPLANT DATE AND EXPLANT DATE, PATIENT DATA, AND EVENT DETAILS. 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 SERIAL NUMBER OR IMPLANT DATE WAS GIVEN. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. BAND SLIPPAGE IS A SURGICAL/PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.