MAUDE Adverse Event Report: MEDLINE RENEWAL; LNCS ADULT PROBE

Catalog Number	1859R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced a "broken finger".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025 "the patient reported the device was hurting her finger, so she asked for it to be removed, the patient reports that the nurse struggled to remove the device, the nurse stated that she didn't have any trouble removing the device, the tech working with the nurse that day reports that the patient did complain of pain in her finger just after the device was removed and requested ice for her finger, by the time the night shift started the nurse caring for the patient and the charge nurse reported that the patient's finger had significant swelling and bruising which is what prompted the request for an x-ray, which revealed the fracture".The sample has been requested for evaluation.No additional information is available at this time.It has been determined that the reported event contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: LNCS ADULT PROBE
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 94456 1876
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22195088
• Report Number: 3032391-2025-00005
• Device Sequence Number: 15780714
• Product Code: NLF
• UDI-Device Identifier: 10888277306356
• UDI-Public: 10888277306356
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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 Catalogue Number: 1859R
• Device Lot Number: PO250423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 83 KG