MAUDE Adverse Event Report: EEZCARE MEDICAL CORP. DRIVE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	14027
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the importer/ initial distributor of the device.Caregiver acquired the device (b)(6) 2016 from a dme provider.Patient used the unit for a month before several bed sores were discovered.Initial treatment was in-house by nurse visitation.Patient was subsequently admitted to the hospital.Patient been in and out of the hospital to treat blisters.Caregiver advised that the unit was installed by dme provider.There is no report of any product defect and/or malfunction.

• Brand Name: DRIVE
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): EEZCARE MEDICAL CORP.; no. 3-1, minquan st; tu-cheng district,; new taipei city, taiwan 23679 ; TW 23679
• MDR Report Key: 6707408
• Report Number: 2438477-2017-00011
• Device Sequence Number: 13916709
• Product Code: FNM
• UDI-Device Identifier: 00822383221618
• UDI-Public: (01)00822383221618
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 01/09/2017
• Report Date (Section F): 02/06/2017

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
• Operator of Device: Patient Family Member or Friend
• Device Model Number: 14027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/09/2017
• Device Age: 12 MO
• Event Location: Home
• Date Report to Manufacturer: 02/06/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2017
• 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: Hospitalization
• Patient Age: 76 YR
• Patient Weight: 84
• Date Report Sent to FDA: 02/06/2017