MAUDE Adverse Event Report: Applied Medical Resources Alexis ® O C-Section Protector - Retractor; Instrument, Manual, Specialized Obstetric-Gynecologic

Model Number	G6313
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Perforation (2001)
Type of Reportable Event	Serious Injury

• Brand Name: Alexis ® O C-Section Protector - Retractor
• Common Device Name: Instrument, Manual, Specialized Obstetric-Gynecologic
• Manufacturer (Section D): Applied Medical Resources; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; +1(949)713-5359
• MDR Report Key: 50891466
• Report Number: 2027111-2026-00729
• Device Sequence Number: 14961805
• Product Code: KNA
• UDI-Device Identifier: 00607915118129
• UDI-Public: (01)00607915118129
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K062907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Operator of Device: Health Professional
• Device Model Number: G6313
• Device Catalogue Number: 101478493
• Device Lot Number: 1573614
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 11/04/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 158 LB
• Patient Race: White