FDA.reportPublic FDA data

MAUDE MDR 4894156

MDR report key
4894156
Report number
3006722112-2015-00182
Event key
0
Event type
3
Date of event
2015-05-22
Date received
2015-07-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
LAURA 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#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)IMPLANT, INTRAGASTRIC FOR MORBID OBESITYALLERGANLTINALAP-BAND ADJUSTABLE SYSTEMNIR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-0101. H; 2. L; 3. R

Event Narratives#

D

Patient 1

PATIENT REPORTED A LAP-BAND "OBSTRUCTION," "EXCRUCIATING PAIN, SEROMA, HEMATOMA, DRAINAGE" AND STATED THAT THE BAND "SHIFTED." THE PATIENT ALSO REPORTED THAT WHEN THE DOCTOR WENT TO "DEFLATE" THE BAND PRIOR TO REMOVAL THERE WAS "NOTHING IN IT." THESE EVENTS WERE FIRST NOTICED WHEN THE PATIENT WAS EXPERIENCING "TOO MUCH PAIN" MAKING IT "DIFFICULT TO SLEEP." THE LAP-BAND SYSTEM WAS REMOVED, BUT NOT REPLACED. THESE EVENTS HAVE NOT BEEN CONFIRMED BY A HEALTHCARE PROFESSIONAL.

N

Patient 1

THE ACCESS PORT CONNECTOR ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AND WAS DISCARDED AFTER SURGERY BASED UPON THE EVENT DATE AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. OBSTRUCTION, SEROMA, PAIN, HEMATOMA, DRAINAGE, AND BAND SLIPPAGE 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 THE CATALOG NUMBER OR SERIAL NUMBER.