MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES KIT: CIRCUMCISION 20/CS

Model Number	56779
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Incident 6 of 9.The product involved in the event is not available for evaluation.A follow-up report will be provided upon conclusion of investigation.Medical action industries is the manufacturer of the circumcision convenience kit containing gauze 4 x 4 8 ply component, cg-1044-8-4 (lot 2507jk228a).The lot manufactured in the complaint convenience kit lot was sourced from supplier, (b)(4).This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.
Event or Problem Description
The customer reported issues with the 4 x 4 cotton gauze contained within circumcision convenience kit manufactured by medical action industries.During approximately nine circumcision cases, small cotton fibers were observed shedding from the gauze, requiring additional time to remove them to prevent retention at the surgical site.No patient injuries were reported as a result of incidents.

• Brand Name: KIT: CIRCUMCISION 20/CS
• Common Device Name: KIT: CIRCUMCISION 20/CS
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): JIANERKANG MEDICAL CO., LTD.; no.1 jianerkang road; industrial zone, zhixi town; changzhou city jiangsu, china
• Manufacturer Contact: nichole coggins ; 25 heywood road; arden, NC 28704 ; 8287820529
• MDR Report Key: 25201126
• Report Number: 1030451-2026-00022
• Device Sequence Number: 21051046
• Product Code: OHG
• UDI-Device Identifier: 20809160006020
• UDI-Public: 20809160006020
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 56779
• Device Catalogue Number: 56779
• Device Lot Number: 340235
• Was Device Available for Evaluation?: No
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown