N/A 11165

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-07-14 for N/A 11165 manufactured by Ascent Halthcare Solutions.

Event Text Entries

[17468464] It was reported that the device would not hold pressure. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5


[17595794] This mdr is associated with an ascent voluntary recall for six (6) femostop lot numbers where the device may fail to inflate properly and may leak due to a seal separation between the dome and plastic arch base. Initially this was not considered a mdr reportable event because there was no patient injury, medical intervention was not required, and ascent had no history of any patient injury due to this type of malfunction. On june 18th ascent initiated a voluntary recall for the six femostop lot numbers so this mdr is being filed due to the recall. The patient information and procedure date were not provided to ascent.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1056128-2010-00036
MDR Report Key1756483
Report Source05,06,07
Date Received2010-07-14
Date of Report2010-07-14
Date Mfgr Received2010-06-18
Device Manufacturer Date2009-11-30
Date Added to Maude2011-04-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. MOIRA BARTON-VARTY
Manufacturer Street10232 S. 51ST STREET
Manufacturer CityPHOENIX AZ 85044
Manufacturer CountryUS
Manufacturer Postal85044
Manufacturer Phone4807635300
Manufacturer G1ASCENT HALTHCARE SOLUTIONS
Manufacturer Street5307 GREAT OAK DRIVE
Manufacturer CityLAKELAND FL 33815
Manufacturer CountryUS
Manufacturer Postal Code33815
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameN/A
Generic NameNMF
Product CodeNMF
Date Received2010-07-14
Returned To Mfg2010-03-21
Model Number11165
Catalog Number11165
Lot Number879990
Device Expiration Date2010-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASCENT HALTHCARE SOLUTIONS
Manufacturer Address5307 GREAT OAK DRIVE LAKELAND FL 33815 US 33815


Patients

Patient NumberTreatmentOutcomeDate
10 2010-07-14

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