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 2013-04-24 for SURESOUND SOUND12 manufactured by Hologic.

Event Text Entries

[18624825] Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, mfr's report number: 1222780-2013-00074. On (b)(6) 2013, the physician performed an uneventful novasure endometrial ablation. On (b)(6) 2013, it was reported the patient returned to the hospital complaining of "a lot of pain. The patient had a fever of 101 degree fahrenheit". A computed tomography (ct) scan revealed "no free air" and "no injury". The patient was then discharged home on amoxicillin.
Patient Sequence No: 1, Text Type: D, B5


[18760416] 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 cannot be completed. Lot number of the suresound not provided by the complainant, therefore the mfr date is not known. Device history record (dhr) and sterile lot 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) other adverse events: the following adverse event could occur or have been reported in association with the use of the novasure system: infection or sepsis. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1222780-2013-00073
MDR Report Key3082961
Report Source05,06,07
Date Received2013-04-24
Date of Report2013-03-25
Date of Event2013-03-25
Date Facility Aware2013-03-25
Date Mfgr Received2013-03-25
Date Added to Maude2013-04-30
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, MGR
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5082638859
Manufacturer G1HOLOGIC
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal Code01752
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURESOUND
Product CodeHHM
Date Received2013-04-24
Model NumberNA
Catalog NumberSOUND12
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC
Manufacturer AddressMARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-04-24

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