MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ETTUBE FASTENR, MBRACE, 2PT STRAP

Catalog Number	DYNJMBRC2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, "a male patient in his 40s presented with a breakdown of the upper lip, including an open wound with active bleeding.The device had been in place on the patient for approximately 2-3 days".The facility reported the location of the breakdown was on the upper lip.The facility declined to comment further.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, "a male patient in his 40s presented with a breakdown of the upper lip, including an open wound with active bleeding.".

• Common Device Name: ETTUBE FASTENR, MBRACE, 2PT STRAP
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20624884
• Report Number: 1417592-2024-00947
• Device Sequence Number: 7453349
• Product Code: CBH
• UDI-Device Identifier: 20193489005308
• UDI-Public: 20193489005308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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: DYNJMBRC2
• Device Lot Number: 24GOA754
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/06/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male