FDA.reportPublic FDA data

MAUDE MDR 4768390

MDR report key
4768390
Report number
3006722112-2015-00041
Event key
0
Event type
3
Date of event
2014-04-20
Date received
2015-05-11
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 ELBOEUF
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#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)IMPLANT, INTRAGASTRIC FOR MORBID OBESITYALLERGANLTINAB-22602185393R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-05-11201. H; 2. R

Event Narratives#

D

Patient 1

HEALTH CARE PROFESSIONAL REPORTED PATIENT WENT TO ER WITH LAP-BAND SLIPPAGE AND OBSTRUCTION. PATIENT ALSO HAD DIFFICULTY SWALLOWING OR KEEPING FOOD DOWN. SOME FLUID REMOVED WITH NO RELIEF OF PAIN. THE LAP-BAND WAS EXPLANTED. PATIENT BECAME PREGNANT AFTER COMPLAINT DEVICE REMOVED.

N

Patient 1

(B)(4). 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 IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. ALLERGAN WILL NOT RECEIVE THE DEVICE AND NO ANALYSIS OR TESTING WILL BE DONE. OBSTRUCTION, BAND SLIPPAGE, DYSPHAGIA, PAIN, AND VOMITING ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING DIAGNOSTIC TESTING OR FURTHER EVENT DETAILS.