MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MATTRESS,SYSTEM,A20,LAL/ALTERNATING PRES

Catalog Number MDT24A20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Erosion (2075)

Event Date 10/03/2023

Event Type  Injury  

Manufacturer Narrative

Per the customer "the mattress sinks in the middle and it's not holding air, and now the customer has a stage 4 ulcer that is not getting any better".No additional information is available at this time.The sample was requested for evaluation.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 Description

Per the customer "the mattress sink in the middle and it's not holding air, and now the customer has a stage 4 ulcer that is not getting any better".

• Type of Device: MATTRESS,SYSTEM,A20,LAL/ALTERNATING PRES
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18003697
• MDR Text Key: 326488603
• Report Number: 1417592-2023-00424
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 10080196549733
• UDI-Public: 10080196549733
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDT24A20
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other