MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MATTRESS,SYSTEM,MEDTECH,BARI,TRUE,42X80

Catalog Number	MDT24B42
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the item arrived damaged, there is a hole that is clearly not a natural low air loss hole, it is visibly a damaged area.".
Additional Manufacturer Narrative
The customer reported that the item arrived damaged and that there is a hole that is clearly not a natural low air loss hole; it is visibly a damaged area, with no damage to the outside box.During investigation, the photo provided was reviewed, and no response was received from the vendor request; the complaint sample would have been sent to the vendor for evaluation and to determine a root cause of the reported issue.The complaint can be confirmed from the photo provided of small hole in the cover.The root cause could not be determined, and a review of the complaint information as well as the results of the investigation indicate no need for further action at this time.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: MATTRESS,SYSTEM,MEDTECH,BARI,TRUE,42X80
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: narendra nambula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50691355
• Report Number: 1417592-2026-34690
• Device Sequence Number: 18555396
• Product Code: FNM
• UDI-Device Identifier: 10080196371945
• UDI-Public: 10080196371945
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/04/2026

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: MDT24B42
• Device Lot Number: 20241119
• 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: 12/24/2024
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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