MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GAUZE,SPONGE,4"X4",12PLY,STERILE,LF,2/PK

Catalog Number	PRM4412HH
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 4" x 4" (prm4412hh) they received this time "was just a bunch strings" and "there was no way for it to absorb anything.".
Additional Manufacturer Narrative
The reported issue was weave too thin; the customer stated the 4" x 4" received this time was "just a bunch strings" and indicated there was "no way for it to absorb anything." at this time no sample of prm4412hh has been received for this complaint, limiting the ability to investigate the issue thoroughly; no inspection records were available for the product lot, the lot from the month before was inspected with no failures related to the complaint issue, and the vendor provided a coa stating all raw materials were accepted for use and meet specification and all internal inspection and test requirements were met.Due to this, the complaint cannot be confirmed, and the cause was documented as sample required to determine cause.At this time a quality issue with the product cannot be confirmed based off the information received, and the divisional quality representative will continue to monitor this issue for tracking and trending purposes during quarterly trending.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: GAUZE,SPONGE,4"X4",12PLY,STERILE,LF,2/PK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870296
• Report Number: 1417592-2026-49045
• Device Sequence Number: 10743185
• Product Code: NAB
• UDI-Device Identifier: 20080196694119
• UDI-Public: 20080196694119
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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): 09/22/2026

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: PRM4412HH
• Device Lot Number: 6052312010
• 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: 06/13/2024
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown