SURESOUND SOUND12

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 2014-08-20 for SURESOUND SOUND12 manufactured by Hologic.

Event Text Entries

[17693334] This report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report# 1222780-2014-00134. It was reported a physician performed a novasure endometrial ablation on (b)(6) 2014 and received several unsuccessful cavity integrity assessment (cia) tests. The physician suspected a perforation at the "mid fundal area", but could not confirm during the hysteroscopy. The procedure was aborted. No intervention was required and the patient was discharged home. A hysteroscopy, dilatation, and sounding with both a suresound device and metal sound (non hologic device) were performed 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


[17786301] Lot number of the suresound not provided by the complainant, therefore the expiration date is unknown. The suresound is not being returned therefore, a failure analysis of the complaint device can not be evaluated. 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 effects: potential adverse events include, but are not limited to perforation of the uterine wall. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1222780-2014-00133
MDR Report Key4044736
Report Source05,06,07
Date Received2014-08-20
Date of Report2014-07-21
Date of Event2014-07-18
Date Mfgr Received2014-07-21
Date Added to Maude2014-08-29
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 ContactCRAIG CALLAHAN
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5082638859
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSURESOUND
Generic NameUTERINE SOUNDING DEVICE
Product CodeHHM
Date Received2014-08-20
Model NumberNA
Catalog NumberSOUND12
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC
Manufacturer AddressMARLBOROUGH MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-08-20

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