MAUDE Adverse Event Report: INRAD, INC. PRECISECORE; PRECISECORE NO THROW BIOPSY DEVICE

Model Number	681014
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Two very small metallic fragments in the area of the needle tract on the post-biopsy mammograms.
Event or Problem Description
Two very small metallic fragments in the area of the needle tract on the post-biopsy mammograms.

• Brand Name: PRECISECORE
• Common Device Name: PRECISECORE NO THROW BIOPSY DEVICE
• Manufacturer (Section D): INRAD, INC.; 4375 donker court se; kentwood MI 49512
• Manufacturer (Section G): INRAD, INC.; 4375 donker court se; kentwood MI 49512
• Manufacturer Contact: megan morrissey ; 4375 donker court se; kentwood, MI 49512 ; 6163017800
• MDR Report Key: 12923391
• Report Number: 1835568-2021-00001
• Device Sequence Number: 17340274
• Product Code: KNW
• UDI-Device Identifier: 00817295020817
• UDI-Public: 00817295020817
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K093399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: 681014
• Device Catalogue Number: 681014
• Device Lot Number: 62101001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female