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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC SURESOUND UTERINE SOUNDING DEVICE

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HOLOGIC, INC SURESOUND UTERINE SOUNDING DEVICE Back to Search Results
Model Number NS2013KIT
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/27/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed. If the device is returned and evaluation completed, a supplemental medwatch will be filed. Device history record (dhr) review was conducted for the reported identification number. The lot was released meeting all qa specifications. Internal reference #: (b)(4).
 
Event Description
It was reported that during uterine sounding, prior to ablation, parts of the plastic malecot and internal probe of the sounding device broke off inside the patient. X-ray images were taken and there were no device fragments seen inside the patient. No further information received.
 
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Brand NameSURESOUND
Type of DeviceUTERINE SOUNDING DEVICE
Manufacturer (Section D)
HOLOGIC, INC
250 campus drive
marlborough MA 01752
Manufacturer Contact
kelsea lyver
250 campus drive
marlborough, MA 01752
5082636130
MDR Report Key9013925
MDR Text Key158154760
Report Number1222780-2019-00210
Device Sequence Number1
Product Code HHM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 08/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/07/2021
Device Model NumberNS2013KIT
Device Catalogue NumberNS2013KIT
Device Lot Number19A07RK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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