MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; WEDGE,FOAM,30 DEGREE,COVERED,NONSLIP,6PR

Catalog Number	MSC50023
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility "during the trial period" the patient experienced a stage ii pressure injury described as "pink wound bed with small area of darker discoloration" in relation to using a 30-degree nonslip foam wedge.
Additional Manufacturer Narrative
According to the facility "during the trial period" the patient experienced a stage ii pressure injury described as "pink wound bed with small area of darker discoloration" in relation to using a 30-degree nonslip foam wedge.Per the facility the pressure injury "was not present on admission when the skin assessment was performed".Per the facility "venelex ointment was ordered at discovery, then triad cream later to heal and protect from incontinence".Per the facility skin checks are performed "every shift and as needed" and the patient is turned "every 2 hours for left and right only and never supine while in bed".Per the facility the patient had a documented braden scale of 10 on the date of the injury and was on vasopressors during their stay.The device is not available for evaluation.No additional information is available related to the reported incident.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: WEDGE,FOAM,30 DEGREE,COVERED,NONSLIP,6PR
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19767013
• Report Number: 1417592-2024-00753
• Device Sequence Number: 12890241
• Product Code: CCX
• UDI-Device Identifier: 40888277327727
• UDI-Public: 40888277327727
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/17/2024

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: MSC50023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/17/2024
• 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: Female
• Patient Weight: 69 KG