FDA.reportPublic FDA data

MAUDE MDR 4814426

MDR report key
4814426
Report number
3006722112-2015-00150
Event key
0
Event type
3
Date of event
2014-06-09
Date received
2015-06-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS 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#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)IMPLANT, INTRAGASTRIC FOR MORBID OBESITYALLERGANLTINAB-22401542724Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-0101. R

Event Narratives#

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTED BAND UNFILLED, "PATIENT COMPLAINED OF VOMITING, NIGHTTIME REFLUX, POOR SOLID FOOD TOLERANCE, AND FREQUENT REGURGITATION". PATIENT CONTINUED TO COMPLAIN OF "NAUSEA AND VOMITING DESPITE HAVING A COMPLETELY EMPTY BAND". DIAGNOSTIC IMAGING SHOWED "DELAYED PASSAGE OF CONTRAST WITH A NARROW OPENING". THE ENTIRE LAP-BAND SYSTEM WAS EXPLANTED.

N

Patient 1

(B)(4). 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 THE SERIAL NUMBER AND IMPLANT 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 DONE. VOMITING, FOOD INTOLERANCE, ESOPHAGEAL DYSMOTILITY, REFLUX AND NAUSEA ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

N

Patient 1

VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED THAT THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE.