MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S

Catalog Number	MDSALINE7
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Osteomyelitis (4533)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the user, "the product was used to clean a pressure wound on my right foot by healthcare professionals and me.The pressure wound was a result of a bone fracture.The doctors prescribed different antibiotics a couple of times to clear skin infection and the iv antibiotic infusion was prescribed to clear the bones infection (30 days long) after the surgery".The customer stated that the treatment was not successful because the "bones in my right leg were also infected and i had tobe treated for chronic osteomyelitis at the hospital".The customer stated was not completely certain this was the fault of the saline but felt that it might be.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.
Event or Problem Description
According to the user, "the product was used to clean a pressure wound on my right foot by healthcare professionals and me.The pressure wound was a result of a bone fracture.The doctors prescribed different antibiotics a couple of times to clear skin infection and the iv antibiotic infusion was prescribed to clear the bones infection (30 days long) after the surgery".

• Brand Name: MEDLINE
• Common Device Name: DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25022166
• Report Number: 1417592-2026-00645
• Device Sequence Number: 13293699
• Product Code: FRO
• UDI-Device Identifier: 10193489089356
• UDI-Public: 10193489089356
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: R-25-267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MDSALINE7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/28/2026
• 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
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-25-267
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White