MAUDE Adverse Event Report: AUSTIN MEDICAL AUSTIN MEDICAL; MOTHER'S VIEWING DRAPE WITH BLEED ID WINDOW

Model Number	AU-10-122NS
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Chloraprep is having an adverse effect with the adhesive on the drape.Once they apply the chlorapret the adhesive won't stay down and they are having to add tagaderm to keep it in place.
Event or Problem Description
Chloraprep is having an adverse effect with the adhesive on the drape.Once they apply the chlorapret the adhesive won't stay down and they are having to add tagaderm to keep it in place.

• Brand Name: AUSTIN MEDICAL
• Common Device Name: MOTHER'S VIEWING DRAPE WITH BLEED ID WINDOW
• Manufacturer (Section D): AUSTIN MEDICAL; 190 industrial park drive; waynesville NC 28786
• Manufacturer (Section G): AUSTIN MEDICAL; 190 industrial park drive; waynesville NC 28786
• Manufacturer Contact: daren reeves ; 190 industrial park drive; waynesville, NC 28786 ; 8043077706
• MDR Report Key: 21599254
• Report Number: 3014527682-2025-00002
• Device Sequence Number: 15688209
• Product Code: KKX
• UDI-Device Identifier: 00850017635418
• UDI-Public: 00850017635418
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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 Model Number: AU-10-122NS
• Device Lot Number: 2304E264,2312E742,2402E132,240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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