MAUDE Adverse Event Report: HOLOGIC, INC. BIOZORB LP; MARKER, RADIOGRAPHIC, IMPLANTABLE

Catalog Number	F0221
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hologic, biozorb lp marker, ref f0221, lot 22a20rl.Use by date does not match box.Product expiration dated contained inside of outer box has different expiration date from outside label.Internal expiration date 2022-02-20, outer box expiration date displays 2024-07-08.Product not used on patient.Reported to vendor.Fda safety report id# (b)(4).

• Brand Name: BIOZORB LP
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 14376111
• Report Number: MW5109654
• Device Sequence Number: 17556141
• Product Code: NEU
• UDI-Device Identifier: 25420045514024
• UDI-Public: (01)25420045514024(17)240708(10)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2022
• Device Catalogue Number: F0221
• Device Lot Number: 22A20RL
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown