MAUDE Adverse Event Report: GD MEDICAL CYLINDRICAL SPONGE 1-1/2 X 1/2, DOUBLE-STRUNG 5/PK 100/CS; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	30-045
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A user facility reported, " it comes out in the throat of patients.So very problematic in surgery for tonsils.Several packaging must be discarded as they are unusable (budgetary consequence).Product sterility may be compromised (risk to user)" the specific problem and adverse event that occurred were not described.Deroyal has requested additional information on the issue and adverse event.A supplier corrective action request (scar) will be been sent to the sponge 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 user facility reported, " it comes out in the throat of patients.So very problematic in surgery for tonsils.Several packaging must be discarded as they are unusable (budgetary consequence).Product sterility may be compromised (risk to user)" the specific problem or adverse event that occurred because of the problem were not described.
Additional Manufacturer Narrative
Deroyal requested additional information on the issue and adverse event on (b)(6) and (b)(6), however, no response from the customer was received.Deroyal reviewed work orders and failure mode and effects analysis (fmea) and no issues were found.A complaint to sales ratio was completed from (b)(6) 2022 to (b)(6) 2023 and calculated to be (b)(4).A supplier corrective action request (scar) was sent to the sponge supplier, (b)(4).(b)(4) requested more information on the issue, but no further information was provided by the customer.(b)(4) reviewed production records and retained samples and found no issues.Root cause: because the device was not returned, no further information was provided by the customer, and no issues were found within production records, no root cause was able to be established.Corrective and preventive actions: because no root cause was able to be established, no corrective or preventive actions were taken.Deroyal will 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: CYLINDRICAL SPONGE 1-1/2 X 1/2, DOUBLE-STRUNG 5/PK 100/CS
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): GD MEDICAL; 1286 humbracht circle; (frmly u-ten / umed); bartlett IL 60103
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1703 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19950640
• Report Number: 1060680-2023-00013
• Device Sequence Number: 8856634
• Product Code: GDY
• UDI-Device Identifier: 50749756028337
• UDI-Public: 50749756028337
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: 30-045
• Device Lot Number: 58671077
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/09/2024
• 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: Required Intervention
• Patient Sex: Unknown