MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SPONGE,LAP,18"X18",STD,XR,ST,5/PK,40PK/C

Catalog Number	MDS241518XI
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "concerns were raised regarding the resistance and quality of the material (fine-weave compress) compared to the standard brand used.Issues include low absorption capacity and size discrepancies, as it only matches the standard dimensions when stretched.".
Additional Manufacturer Narrative
The reporter described concerns regarding the resistance and quality of the material (fine-weave compress) compared to the standard brand used, including low absorption capacity and size discrepancies, as it only matches the standard dimensions when stretched.The customer did not provide physical or photo samples for review, and analysis of complaint data was performed with trending conducted over the past two years by all versions of the product.Based on the results of the investigation, medline was unable to confirm the reported issue or that the product failed to meet specifications; without a physical sample or picture, the ability to establish that the root cause was directly related to the manufacturing of the product was limited.It was determined that there were no other complaints with this product regarding this issue, making this an isolated incident, and no serious injury or death was associated with this complaint.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: SPONGE,LAP,18"X18",STD,XR,ST,5/PK,40PK/C
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947974
• Report Number: 1417592-2026-54534
• Device Sequence Number: 15859059
• Product Code: GDY
• UDI-Device Identifier: 10193489091076
• UDI-Public: 10193489091076
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Device Catalogue Number: MDS241518XI
• Device Lot Number: 84322100083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 09/30/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown