SURESOUND SOUND12-923001-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-15 for SURESOUND SOUND12-923001-01 manufactured by Hologic, Inc.

Event Text Entries

[59975018] Lot number of the suresound not provided by the complainant, therefore the expiration date is not known. The suresound is not being returned therefore, a failure analysis of the complaint device can not be completed. Lot number of the suresound not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review could not be conducted for the suresound as a lot number was not provided by the complainant. According to the instructions for use (ifu) adverse events: potential adverse events include, but are not limited to perforation of the uterine wall (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[59975019] Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report# 1222780-2016-00270. It was reported the physician attempted to perform a novasure endometrial ablation on (b)(6) 2016 and received several unsuccessful cavity integrity assessment (cia) tests using two disposable devices. After the physician removed the second device, a hysteroscopy was performed and the physician saw a small perforation. No intervention was required. The procedure was aborted and the patient was discharged home.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2016-00273
MDR Report Key6103664
Date Received2016-11-15
Date of Report2016-10-18
Date of Event2016-10-07
Date Mfgr Received2016-10-18
Date Added to Maude2016-11-15
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 FDA3
Event Location3
Manufacturer ContactMS. SIDRA PIRACHA
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5082638884
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSURESOUND
Generic NameUTERINE SOUNDING DEVICE
Product CodeHHM
Date Received2016-11-15
Catalog NumberSOUND12-923001-01
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC, INC
Manufacturer Address250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-11-15

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