MAUDE Adverse Event Report: XIAMEN WOELD GEAR SPORTS GOODS DRIVE; BED

Model Number	P750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) is the initial importer of the device which is a bed.The device has not been returned for evaluation.A follow-up will be submitted when additional data is available.The user hit the bed with while using her power chair.We do not know the make or model number of the power chair.The user.The end-user has been given a bariatric rented bed.She hit the lower part on the side of the bed while in her power wheelchair.She received two incisions to bilat legs which required numerous sutures to bilateral lower legs.The service provider returned the device frame back to their warehouse for an extensive analysis with the area with their service techs.The technicians could not find anything wrong or unusual on the frame.Though they cannot be certain how it happened, they believe the event must have occurred related to the patient's power chair and how it was being handled.

• Brand Name: DRIVE
• Common Device Name: BED
• Manufacturer (Section D): XIAMEN WOELD GEAR SPORTS GOODS; 27-29 n 2nd rd; fujian, xiamen 36102 2; CH 361022
• MDR Report Key: 12698026
• Report Number: 2438477-2021-00061
• Device Sequence Number: 19759534
• Product Code: OSI
• UDI-Device Identifier: 00822383003078
• UDI-Public: 00822383003078
• 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): 10/26/2021
• Report Date (Section F): 10/26/2021

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: Lay User/Patient
• Device Model Number: P750
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/04/2021
• Device Age: 15 MO
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2021
• 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
• Date Report Sent to FDA: 10/26/2021