MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES SPONGE SPECIALTY K-DISS XR 100-CS

Model Number	7102
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in this event is available for evaluation.The complaint component sponge kitter dissector part number 9160-02 is manufactured by carwild corporation (fda registration 1219313).A scar was issued to the supplier on (b)(6) 2024.A follow-up report will be provided upon conclusion of investigation and response by the supplier.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 doctor reported the sponges were unraveling and flaking into little pieces.The incident was identified during thyroid surgery and the surgery was prolonged as a result of the issue.The surgeon picked all the little pieces out of the wound which took time and intricacy.
Additional Manufacturer Narrative
Medical action industries repackages the sponges provided by carwild.Medical action industries has no other complaints for this issue received in the past three years.Carwild performed an investigation of sponge lot number.Device history record was reviewed, there were no findings.No deviations were reported during manufacture.Raw materials and manufacturing equipment were reviewed.There were no changes or issues noted.A root cause was not established, this appears to be an isolated incident.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.

• Brand Name: SPONGE SPECIALTY K-DISS XR 100-CS
• Common Device Name: SPONGE SPECIALTY K-DISS XR 100-CS
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): CARWILD CORPORATION; 3 state pier road; new london CT 06320
• Manufacturer Contact: nichole coggins ; 25 heywood road; arden, NC 28704 ; 8287820529
• MDR Report Key: 20732699
• Report Number: 1030451-2024-00022
• Device Sequence Number: 12854621
• Product Code: GDY
• UDI-Device Identifier: 20809160015633
• UDI-Public: 20809160015633
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 7102
• Device Catalogue Number: 7102
• Device Lot Number: 319552
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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