MAUDE Adverse Event Report: POLIURETANOS, S.A. DE C.V. DRIVE; PRESSURE REDISTRIBUTION FOAM MATTRESS

Model Number	6500-DE-2-FB
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	05/03/2022
Type of Reportable Event	No Answer Provided
Event or Problem Description
Drive devilbiss healthcare was contacted regarding a reported injury involving a pressure redistribution foam mattress, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user, who is bedridden, reported having developed bed sores after 8 months of use, reportedly due to the mattress becoming very hot.Drive did not receive any information regarding the patient's overall pressure injury management program.Drive is currently investigating the incident, including attempting to retrieve the product to evaluate it.Drive will update this filing if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: PRESSURE REDISTRIBUTION FOAM MATTRESS
• Manufacturer (Section D): POLIURETANOS, S.A. DE C.V.; alfredo nobel s/n; zona industrial; toluca 50010 ; MX 50010
• MDR Report Key: 15015277
• Report Number: 2438477-2022-00065
• Device Sequence Number: 2517906
• Product Code: IKY
• UDI-Device Identifier: 00822383516431
• UDI-Public: 822383516431
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2022
• Report Date (Section F): 07/14/2022

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?: No
• Device Model Number: 6500-DE-2-FB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 07/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 147 KG
• Date Report Sent to FDA: 07/14/2022