MAUDE Adverse Event Report: DRIVE; BED

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Laceration(s) (1946)

Event Date 03/01/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a bed by an end user's sister, stating that as a result of her sister falling out of her bed, she has had to seek medical attention because the bed "took off skin on her back and bottom." the reporter did not make clear whether there was any defect in the bed that caused the end user's skin to be compromised, or identify any such defect.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: BED
• MDR Report Key: 17004320
• MDR Text Key: 315963416
• Report Number: 2438477-2023-00047
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2023
• Distributor Facility Aware Date: 04/27/2023
• Date Report to Manufacturer: 06/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 136 KG