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

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.

• Brand Name: LOCALIZER
• Type of Device: MARKER, 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 Key: 12345108
• MDR Text Key: 267357207
• Report Number: 3013649990-2021-00007
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HB200-07
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/19/2021
• 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 Sequence Number: 1
• Treatment: LOCALIZER READER
• Patient Outcome(s): Other