FDA.reportPublic FDA data

MAUDE MDR 5010477

MDR report key
5010477
Report number
3006722112-2015-00283
Event key
0
Event type
3
Date of event
2015-04-17
Date received
2015-08-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LAURA LEBOUF
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 (SMALL)IMPLANT, INTRAGASTRIC FOR MORBID OBESITYALLERGANLTIN/AB-202602468654R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-140

Event Narratives#

N

Patient 1

(B)(4). TAPER II. MEDWATCH SENT TO FDA ON 08/14/2015. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS AS WELL AS TO INDICATE THE PRODUCT SERIAL NUMBER OR MODEL NUMBER. THE DEVICE HAS NOT YET BEEN RECEIVED BY (B)(4). BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER, THE CONNECTOR TYPE IS 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. SEE SCANNED PAGE.

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTED "BAND WAS FAULTY SNAPPED, WHILST TRYING TO INSERT."