MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES ALEXIS WOUND PROTECTOR-RETRACTOR; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8301
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	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Name of procedure being performed: lar detailed description of event: hospital: [name] hospital, distributor: [distributor's name], event date: 24dec2024, model #: c8301, lot #: 1531392.Before the surgery, the scrub nurse noticed a short hair inside the product packaging immediately after opening it.As a result, the product was not used and was returned.User replace with a new one to complete this surgery.Please refer to the attached photo for reference.Patient status: na (before use) type of intervention: user replace with a new one to complete this surgery.
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: lar.Detailed description of event: hospital: [name] hospital.Distributor: [distributor's name].Event date: 24dec2024.Model #: c8301.Lot #: 1531392.Before the surgery, the scrub nurse noticed a short hair inside the product packaging immediately after opening it.As a result, the product was not used and was returned.User replace with a new one to complete this surgery.Type of intervention: na (before use).Patient status: na (before use).
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of a loose hair between the instrument shield and alexis.Based on the condition of the returned unit and the description of the event, it is likely that the loose hair originated from an operator during the manufacturing process.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• Brand Name: ALEXIS WOUND PROTECTOR-RETRACTOR
• 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: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 21074510
• Report Number: 2027111-2025-00304
• Device Sequence Number: 20541062
• Product Code: KGW
• UDI-Device Identifier: 00607915117207
• UDI-Public: (01)00607915117207
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: C8301
• Device Catalogue Number: 101478494
• Device Lot Number: 1531392
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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