MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; RAIL,CLAMP-ON HALF F/ MEDLINE HMC

Catalog Number	MDS89697
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the edges of her handrails being sharp, ¿knife railings¿.".
Additional Manufacturer Narrative
The customer reported a sharp edge on the side rail, and the customer correspondence stated the edges of her handrails were sharp, ¿knife railings¿; there were no injuries involved at the time the email was sent.Medline received 1 pair of bed half rails in used condition and inspected the product per pic-00255; upon further investigation of the sample it was discovered that there are several slightly sharp edges on the top edge where you may slide your hand.The investigation results were confirmed, and the result of the pic testing was functional defect.The cause was documented as mfg: assembly/human error, and the division will monitor through 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: RAIL,CLAMP-ON HALF F/ MEDLINE HMC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50917037
• Report Number: 1417592-2026-52265
• Device Sequence Number: 5344902
• Product Code: FNJ
• UDI-Device Identifier: 40080196746027
• UDI-Public: 40080196746027
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/25/2026

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: MDS89697
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/19/2023
• 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: 06/15/2023
• Initial Report FDA Received Date: 09/28/2026
• 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