• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEALTH BACONS, INC LOCALIZER MARKER, RADIOGRAPHIC, IMPLANTABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HEALTH BACONS, INC LOCALIZER MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number HB100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2021
Event Type  Injury  
Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number. The device was released meeting all qa specifications. We are currently unable to establish a relationship between the device and the issue reported. The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed. We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined. The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends. If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
 
Event Description
It was reported that during a breast surgery on july 15th, the physician using the localizer reader was not able to find the localizer tag during the procedure. It was reported that the tag was placed on a margin for the sample to be collected 1 week before and during the procedure the tag was separated from the sample and fell into the breast cavity where it was sucked by the suction line. The physician due to not being able to find the tag had to perform an additional excision on the sample and the patient had to be kept over 1 additional hour under general anesthesia. The tag was wound at the end of the procedure in one of the cannisters where the suction line ends. No other information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLOCALIZER
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
HEALTH BACONS, INC
250 campus drive
marlborough MA 01752
Manufacturer (Section G)
RANFAC CORPORATION
30 doherty avenue
avon MA 02322
Manufacturer Contact
sumanesh agrawal
250 campus drive
marlborough
MDR Report Key12315848
MDR Text Key266301519
Report Number3013649990-2021-00006
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberHB100
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/12/2021 Patient Sequence Number: 1
Treatment
LOCALIZER TAG AND SURGICAL PROBE
-
-