SURESOUND SOUND12

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-08-05 for SURESOUND SOUND12 manufactured by Hologic, Inc.

Event Text Entries

[51302131] 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


[51302132] Note: this report pertains to the second of first hologic devices used in the same procedure. See associated medwatch, manufacturer's report# 1222780-2016-00198. It was reported a physician performed a novasure endometrial ablation on (b)(6) 2016 and the physician received an unsuccessful cavity integrity assessment (cia) test using two disposable devices. The physician then performed a hysteroscopy and "noticed a small perforation at the fundus". The procedure was aborted. No medical intervention was required. Dilatation performed (not a hologic device) prior to the attempted ablation. It is not known when this perforation occurred or what instrument may have been the cause.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1222780-2016-00197
MDR Report Key5851185
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-08-05
Date of Report2016-07-08
Date of Event2016-07-08
Date Mfgr Received2016-07-08
Date Added to Maude2016-08-05
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 ContactMR. 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 Report3

Device Details

Brand NameSURESOUND
Generic NameSOUNDING INSTRUMENT
Product CodeHHM
Date Received2016-08-05
Catalog NumberSOUND12
Lot NumberUNKNOWN
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 2016-08-05

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