D
Patient 1
HEALTHCARE PROFESSIONAL REPORTED GASTRIC PROLAPSE/BAND SLIPPAGE; A LAP-BAND AP SYSTEM REVISION SURGERY, SPECIFIED AS "GASTRIC BAND UNBUCKLING" TOOK PLACE TO TREAT THIS EVENT.
MAUDE MDR 4911512
- MDR report key
- 4911512
- Report number
- 3006722112-2015-00199
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-07-22
- Date received
- 2015-07-10
- 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
- LAURA LEBOEF
- Address
- 1120 S CAPITAL OF TX 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 | 2015-07-10 | 0 | 1. R |
Event Narratives#
N
Patient 1
TAPER II. MEDWATCH SENT TO FDA ON: (B)(4) 2015: THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT YET BEEN RETURNED. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE 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. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF BAND SLIPPAGE AS FOLLOWS: 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.