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U.S. Department of Health and Human Services

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

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HEALTH BACONS, INC LOCALIZER MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number HB200-07
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2021
Event Type  Injury  
Manufacturer Narrative
Lot and serial number of the device not provided by the complainant were not adequate; therefore, the udi, expiration and manufacturing dates are not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant. 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 localizer procedure on july 23rd the physician was not able to read the tag due to a possible interference due to a magnet that was used on a spinal stimulator to turn it off. The tag was read 45 min before the procedure, and it was working accordingly. The tag was implanted 1 week prior to the procedure. The magnet was reported been placed at around 5 to 8 cm from the tag. The surgery had to be rescheduled. In the next surgery it was observed that the tag had migrated 5-7 cm from the original placement. The tag was removed without issues and the surgery was completed. No other information is available.
 
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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, MA 01752
MDR Report Key12345108
MDR Text Key267357207
Report Number3013649990-2021-00007
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 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberHB200-07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/19/2021 Patient Sequence Number: 1
Treatment
LOCALIZER READER
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