MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SPONGE,LAP,18"X18",DLX,XR,ST,5/PK

Catalog Number	MDS251518LFH
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2025, a lap sponge that was "used on patient in incision to soak up blood" was found to have a hair in it.
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025, a lap sponge that was "used on patient in incision to soak up blood" was found to have a hair in it.The customer said that the "hair was in incision and removed off the field." the customer reported that "all other laps from the back were also removed from the field" and that the surgical site was "irrigated with betadine." the customer stated that there is "no injury or infection known at this time." the customer reported there was no serious injury, medical intervention, or follow-up care required related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: SPONGE,LAP,18"X18",DLX,XR,ST,5/PK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23062237
• Report Number: 1417592-2025-00476
• Device Sequence Number: 15949325
• Product Code: GDY
• UDI-Device Identifier: 20080196743923
• UDI-Public: 20080196743923
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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 Catalogue Number: MDS251518LFH
• Device Lot Number: 84325040029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 118 KG