MAUDE Adverse Event Report: UNKNOWN DRIVE BED, MANUAL

Model Number UNKNOWN

Device Problem Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2020

Event Type  malfunction  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a bed. This report is in response of a medwatch filing number mw5100210. We are filing this report to correct some of the information of the initial filing. The device reportedly had exposed parts in which the end-user's hair became entangled. There was no injury.

• Brand Name: DRIVE
• Type of Device: BED, MANUAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11850358
• MDR Text Key: 261734817
• Report Number: 2438477-2021-00014
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/18/2021,05/19/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2021
• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage