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
Additional Manufacturer Narrative
According to the facility the patient was found "with area of partial thickness erosion with surrounding non bleachable purple discoloration over the midthoracic vertebral process, presentation consistent with deep tissue injury".Per the facility they applied "venelex" and "covered with bordered foam dressing and continued repositioning every 2 hours".Per the facility the patient was using the foam wedge which was described as "very firm", and the facility is "unsure how this may have impacted injury development".The device is not available for evaluation.No additional information is available at this time.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.
Event or Problem Description
According to the facility the patient was found "with area of partial thickness erosion with surrounding non bleachable purple discoloration over the midthoracic vertebral process, presentation consistent with deep tissue injury.".

• 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: 19949314
• Report Number: 1417592-2024-00792
• Device Sequence Number: 18373665
• 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): 08/09/2024

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: 07/15/2024
• Initial Report FDA Received Date: 08/09/2024
• 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: Unknown