MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8404, XL ALEXIS O WND PROT/RET 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8404
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: na (incoming inspection).Detailed description of event: [facility] incoming inspection po#(b)(6).We would like to inform you that some of the products didn't pass our receiving inspection.Please find attached spreadsheet.C8404 lot #1453797 (1 ea.) - particulate: hair.Products available for return.Patient status: na (no patient involvement).Type of intervention: na (incoming inspection).
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of hair inside the sterile unopened pouch.Based on the condition of the returned unit and the description of the event, the hair likely originated from an operator during the manufacturing process.
Event or Problem Description
Name of procedure being performed: na (incoming inspection).Detailed description of event: [distributor] incoming inspection po#(b)(4).We would like to inform you that some of the products didn't pass our receiving inspection.Please find attached spreadsheet.C8404 lot #1453797 (1 ea.) - particulate: hair products available for return.Patient status: na (no patient involvement).Type of intervention: na (incoming inspection).

• Brand Name: C8404, XL ALEXIS O WND PROT/RET 5/BX
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15821099
• Report Number: 2027111-2022-00825
• Device Sequence Number: 14641237
• Product Code: KGW
• UDI-Device Identifier: 00607915117283
• UDI-Public: (01)00607915117283(17)250619(30)01(10)1453797
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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: Other
• Device Expiration Date: 06/19/2025
• Device Model Number: C8404
• Device Catalogue Number: 101356401
• Device Lot Number: 1453797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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