MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; OVERLAY,SYSTEM,SUPRA EXO,LAL/ALT. PRESS

Model Number	MDT24SUPRAEXO
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the mattress overlay would not remain inflated.The end-user experienced a pressure sore to the left upper buttock "near the tailbone" and has required hourly position changes and the application of mediplex patches to the pressure sore.No further adverse impact was reported.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined at this time.Due to the reported need for medical intervention to treat the pressure sore, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the mattress overall would not remain inflated.
Additional Manufacturer Narrative
A sample was returned to the manufacturer with sample evaluation completed on 15-aug-2021.The mattress overlay sample was attached to an air pump and it was able to be inflated to full air capacity.After inflation, the mattress overlay began to alternate as intended and it was able to maintain support even with the application of weight of approximately 170 lbs.The returned sample functioned as intended with no problem/issue identified.The reported product problem/issue was unable to be confirmed and a root cause for the reported incident was not determined.If additional relevant information becomes available another supplemental medwatch will be filed.

• Brand Name: MEDLINE
• Common Device Name: OVERLAY,SYSTEM,SUPRA EXO,LAL/ALT. PRESS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11891484
• Report Number: 1417592-2021-00089
• Device Sequence Number: 847915
• Product Code: FNM
• UDI-Device Identifier: 10080196372201
• UDI-Public: 10080196372201
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MDT24SUPRAEXO
• Device Catalogue Number: MDT24SUPRAEXO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention