CONTOUR CORE SCULPTING SYSTEM M2 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-11-29 for CONTOUR CORE SCULPTING SYSTEM M2 NA manufactured by Contour Technology.

Event Text Entries

[2401253] Customer called our customer service center to "let us know" that she suffered an appendix attack which ruptured and she was hospitalized. Purchase date was (b)(6) 2011. On a subsequent call back, she stated that she was using the contour core sculpting system for months but noticed she had, what she thought was gas pains for 3 days and she sought medical attention. She was hospitalized and received an appendectomy and treated with antibiotics for a ruptured appendix. Customer stated that her daughter "threw the product away" during her hospital stay. She is fully recovered.
Patient Sequence No: 1, Text Type: D, B5


[9601191] There is no evidence or confirmation that device played any role in injury. This was speculation from the customer. A refund was issued in spite of the device not being returned. Contour has closed this case due to lack of f/u material. Refund was issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006348601-2011-00001
MDR Report Key2395051
Report Source01
Date Received2011-11-29
Date of Report2011-11-14
Date of Event2011-09-15
Date Facility Aware2011-10-05
Report Date2011-11-16
Date Added to Maude2012-01-04
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street701 WING ON PLAZA, 62 MODY RD TSIM SHA TSUI EAST
Manufacturer CityKOWLOON
Manufacturer CountryHK
Manufacturer G1DISPLAYTECH LTD.
Manufacturer Street1501-2 EMPRESS PLZ, 17-19 CHATHAM RD S, TSIM SHA TSUI
Manufacturer CityKOWLOON
Manufacturer CountryHK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONTOUR CORE SCULPTING SYSTEM
Generic NameCONTOUR CORE BELT
Product CodeNGX
Date Received2011-11-29
Model NumberM2
Catalog NumberNA
Lot NumberNOT AVAILABLE
Device AvailabilityN
Device Age6 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONTOUR TECHNOLOGY
Manufacturer AddressMINNEAPOLIS MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2011-11-29

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