MAUDE Adverse Event Report: GD MEDICAL NS SGL STR TONSIL SPG 1" LARGE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	30-038NS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A distributing facility reported through a medwatch, "cotton ball falls off string during use." deroyal industries, inc.Requested return of the device but it was stated it was not available.A supplier corrective action request (scar) has been issued to the supplier, gd medical.This investigation is not complete at this time.No further information is available at this time.We will provide follow up report when additional information becomes available.
Event or Problem Description
A distributing facility reported through a medwatch, "cotton ball falls off string during use.".
Additional Manufacturer Narrative
A distributing facility reported through a medwatch, "cotton ball falls off string during use." deroyal industries, inc.Requested return of the device but it was stated it was not available.Because the lot number was not provided, the device history record was unable to be reviewed for the affected product.An inventory check was completed on 2 lots of the raw material and no issues were found.A complaint to sales ratio was conducted over the past two years and found to be 0.002%.A supplier corrective action request (scar) has been issued to the supplier, (b)(4).Samples of existing inventory and the work in progress were tested and no duplication of the same issues were identified.Review of process controls of string attachment were also reviewed.Root cause: because the lot number nor sample were returned and no issues were found within the manufacturing process, the root cause could not be determined.Corrective and preventive actions: qa and workshop supervisors were notified of this incident.Reinforced operator training on string attachment process and increased in-process sampling.Periodic verification of attachment strength during production, and ongoing monitoring of compliant trends was also established.Deroyal will also continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: NS SGL STR TONSIL SPG 1" LARGE
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): GD MEDICAL; 1286 humbracht circle; bartlett IL 60103
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849
• MDR Report Key: 24388011
• Report Number: 2320762-2026-00003
• Device Sequence Number: 21404815
• Product Code: GDY
• UDI-Device Identifier: 00749756162920
• UDI-Public: 00749756162920
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 30-038NS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/26/2026
• 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
• Patient Sex: Unknown