MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; POSITIONER,COMFORT TOUCH,2-LYR,28CS

Catalog Number	NON081147
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they are not expanding as they should.".
Additional Manufacturer Narrative
The customer reported a problem with the headrest positioner, and the items are not expanding as they should; the anesthesia provider has refused to use some of them.Medline quality received 2 ea of the product for evaluation, and visual inspection was conducted with the provided samples.It was found that the items are defective, and the reported concern was confirmed; the suspected root cause is undetermined at this time.The manufacturing site has been notified of this issue, and a retrospective review of the past year for this product indicated that there have been no prior complaints in regard to this issue; the division will continue to monitor the issue for 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: POSITIONER,COMFORT TOUCH,2-LYR,28CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50949271
• Report Number: 1417592-2026-54725
• Device Sequence Number: 13167749
• Product Code: CCX
• UDI-Device Identifier: 40080196413257
• UDI-Public: 40080196413257
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/29/2026

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: NON081147
• Device Lot Number: 294477
• 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: 01/18/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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