MAUDE Adverse Event Report: O&M HALYARD, INC HALYARD; SURGICAL DRAPE-NON-STERILE 12

Model Number	97490
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gown was contained within roi cps, llc custom procedure kit 880218, lot number 85726h.The complainant indicated that 4 gowns were affected.
Event or Problem Description
Adhesive on the drape is not sticking to the patient.Discovered during procedure.No delay to case.No harm to the patient.

• Brand Name: HALYARD
• Common Device Name: SURGICAL DRAPE-NON-STERILE 12
• Manufacturer (Section D): O&M HALYARD, INC; 1 edison dr; alpharetta GA 30005
• MDR Report Key: 11592327
• Report Number: 3014537682-2021-00003
• Device Sequence Number: 3396657
• Product Code: KKX
• UDI-Device Identifier: 30680651794902
• UDI-Public: 30680651794902
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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: 97490
• Device Lot Number: AC20162261 AND AC2027124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1