MAUDE Adverse Event Report: LEICA BIOSYSTEMS RICHMOND INC. PERMAFLEX PLUS ADHESIVE SLIDES, WHITE; SLIDES, MICROSCOPE

Model Number	PERMAFLEX PLUS ADHESIVE SLIDES, WHITE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history review was completed.There were no deviations or non-conformances associated with this lot.Trending analysis reported no (0) other related occurrence of this issue for this product lot.Quality control testing was complete and passed.If additional information is received an additional follow up mdr will be submitted.
Event or Problem Description
On 03 april 2025, leica biosystems received the following information: "tissue is falling off the slides; 2nd section falls off, oven is used 30 min, affects only ihc, not all sections fall off.No irretrievable tissue loss was reported.".
Additional Manufacturer Narrative
Manufacturer testing of retain samples was unable to replicate the "tissue is falllng [sic] off the slides during ihc" reported by the customer.The root cause for the "tissue is falllng [sic] off the slides during ihc" reported by the customer could not be unequivocally determined from the information available.No adverse consequence(s) to a patient(s) has been reported to the manufacturer to date.If additional information is received an additional follow up mdr will be submitted.

• Brand Name: PERMAFLEX PLUS ADHESIVE SLIDES, WHITE
• Common Device Name: SLIDES, MICROSCOPE
• Manufacturer (Section D): LEICA BIOSYSTEMS RICHMOND INC.; 5205 us-12; richmond IL 60071
• Manufacturer (Section G): LEICA BIOSYSTEMS RICHMOND INC.; 5205 us-12; richmond IL 60071
• Manufacturer Contact: heather jensen ; 5205 us-12; richmond, IL 60071 ; 8152988371
• MDR Report Key: 21947197
• Report Number: 1419341-2025-00027
• Device Sequence Number: 8358590
• Product Code: KEW
• UDI-Device Identifier: 20849832023146
• UDI-Public: 20849832023146
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: 02/25/2026
• Device Model Number: PERMAFLEX PLUS ADHESIVE SLIDES, WHITE
• Device Catalogue Number: 3800014
• Device Lot Number: 022525-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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
• Patient Sex: Unknown