FDA.reportPublic FDA data

MAUDE MDR 8333247

MDR report key
8333247
Report number
1832475-2019-00001
Event key
0
Event type
3
Date of event
2009-06-06
Date received
2019-02-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
MR. JOHN PICHON
Address
7625 WEST NEW YORK STREET INDIANAPOLIS IN 46214 US
Phone
317-317-3172
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FLOTECINGAGE REGULATORFLOTEC INC.CANR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-1201. R

Event Narratives#

N

Patient 1

DUE TO LACK OF CONTACT INFORMATION, WE WERE UNABLE TO CONTACT THE REPORTING INDIVIDUAL TO OBTAIN THE UNIT IN QUESTION FOR INVESTIGATION. WE WOULD LIKE TO NOTE THAT THE INGAGE REGULATOR IS NOT INTENDED AS A LIFE-SUSTAINING DEVICE. WE CONDUCTED AN INVESTIGATION ON THE MANUFACTURING OF OUR INGAGE REGULATORS. THE GAUGE FUNCTIONS BY A MOVING MEASURING DEVICE ATTACHED TO AN OUTER DECAL RING WHICH DISPLAYS THE PRESSURE MEASUREMENT. AT THE TIME OF THE REPORTED INCIDENT, OUR MANUFACTURING PROCESS RELIED ON A PURELY MECHANICAL CONNECTION BETWEEN THE MEASURING DEVICE AND THE DECAL. THERE EXISTED THE POTENTIAL FOR THE DECAL TO BECOME DISCONNECTED FROM THE MEASURING DEVICE. IF THIS OCCURS, THE DISPLAY WOULD NOT CHANGE IN RESPONSE TO PRESSURE CHANGES, AND THE REPORTED DEVICE MALFUNCTION COULD OCCUR. IN OUR CURRENT MANUFACTURING PROCESS, THE DECAL IS ATTACHED TO THE MEASURING DEVICE BY A MECHANICAL CONNECTION AS WELL AS AN ADHESIVE. THIS ADDITIONAL STEP IN OUR MANUFACTURING PROCESS GREATLY REDUCES THE RISK OF THE DECAL DETACHING FROM THE MEASURING DEVICE AND CAUSING A FAILURE MODE SIMILAR TO THE REPORTED INCIDENT.

D

Patient 1

THIS REPORT IS OUR RESPONSE TO REPORT NUMBER MW5012641 WITH MDR REPORT KEY (B)(4). THAT REPORT WAS ISSUED ON 08/27/2009. DUE TO LACK OF CONTACT INFORMATION, WE WERE UNABLE TO CONTACT THE REPORTING INDIVIDUAL TO OBTAIN THE UNIT IN QUESTION FOR INVESTIGATION. WE WOULD LIKE TO NOTE THAT THE INGAGE REGULATOR IS NOT INTENDED AS A LIFE-SUSTAINING DEVICE. WE CONDUCTED AN INVESTIGATION ON THE MANUFACTURING OF OUR INGAGE REGULATORS. THE GAUGE FUNCTIONS BY A MOVING MEASURING DEVICE ATTACHED TO AN OUTER DECAL RING WHICH DISPLAYS THE PRESSURE MEASUREMENT. AT THE TIME OF THE REPORTED INCIDENT, OUR MANUFACTURING PROCESS RELIED ON A PURELY MECHANICAL CONNECTION BETWEEN THE MEASURING DEVICE AND THE DECAL. THERE EXISTED THE POTENTIAL FOR THE DECAL TO BECOME DISCONNECTED FROM THE MEASURING DEVICE. IF THIS OCCURS, THE DISPLAY WOULD NOT CHANGE IN RESPONSE TO PRESSURE CHANGES, AND THE REPORTED DEVICE MALFUNCTION COULD OCCUR. IN OUR CURRENT MANUFACTURING PROCESS, THE DECAL IS ATTACHED TO THE MEASURING DEVICE BY A MECHANICAL CONNECTION AS WELL AS AN ADHESIVE. THIS ADDITIONAL STEP IN OUR MANUFACTURING PROCESS GREATLY REDUCES THE RISK OF THE DECAL DETACHING FROM THE MEASURING DEVICE AND CAUSING A FAILURE MODE SIMILAR TO THE REPORTED INCIDENT.