MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION ALEXIS WOUND PROTECTOR/RETRACTOR; DRAPE, SURGICAL

Model Number C8402

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2023

Event Type  malfunction  

Event Description

During the procedure an alexis wound retractor was opened to be used, upon the surgeon unraveling the alexis wound retractor a small piece of plastic like material fell out.The foreign material was then placed in a specimen cup and removed off the field.Management was notified and the object was handed off to them.

• Brand Name: ALEXIS WOUND PROTECTOR/RETRACTOR
• Type of Device: DRAPE, SURGICAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 16582147
• MDR Text Key: 311679170
• Report Number: 16582147
• Device Sequence Number: 1
• Product Code: KKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: C8402
• Device Lot Number: 1450642
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Sex: Female
• Patient Race: White