FDA.reportPublic FDA data

MAUDE MDR 3823307

MDR report key
3823307
Report number
2024601-2014-00071
Event key
0
Event type
3
Date of event
2014-01-09
Date received
2014-02-19
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
KAREN HERRERA
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 10.0CMIMPLANT, INTRAGASTRIC FOR MORBID OBESITYALLERGANLTINAB-2220622140R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-02-190

Event Narratives#

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTED "THE PATIENT [NOTICED A] CHANGE IN RESTRICTION FROM GREAT RESTRICTION TO NO RESTRICTION. THE PHYSICIAN IDENTIFIED "THE RING OF THE BAND (PILLOW THAT HOLDS THE SALINE) HERNIATED TO THE OUTER SIDE OF THE OUTER SHELL OF THE BAND." THE SURGEON INTENDS ON REMOVING AND REPLACING THE ENTIRE LAP-BAND SYSTEM. IT IS NOT KNOWN WHEN THE LAP-BAND SYSTEM WILL BE EXPLANTED OR REPLACED.

N

Patient 1

THE PRODUCT ASSOCIATED WITH THIS REPORT HAS NOT BEEN RETURNED AS THE DEVICE WAS NOT EXPLANTED. BASED UPON THE MODEL 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, IF IT IS EXPLANTED IN THE FUTURE. THE SURGERY HAS NOT OCCURRED, SO ALLERGAN HAS NOT RECEIVED THE DEVICE NOR PERFORMED ANALYSIS AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER. DEVICE LABELING INSTRUCTS SURGEONS TO PREPARE THE LAP-BAND SYSTEM PREPARATION: "VIEW THE INFLATABLE PORTION OF THE BAND FOR WEAKNESSES, LEAKS OR UNEVEN INFLATION."

N

Patient 1

MEDWATCH SENT TO FDA ON 07/17/2015.

N

Patient 1

MEDWATCH SENT TO FDA ON 01/16/2015. HEALTHCARE PROFESSIONAL REPORTED LAP-BAND SYSTEM WAS EXPLANTED.

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTED LAP-BAND SYSTEM WAS EXPLANTED.