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UNKNOWN DRIVE BED, MANUAL Back to Search Results
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.
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Brand NameDRIVE
Type of DeviceBED, MANUAL
Manufacturer (Section D)
MDR Report Key11850358
MDR Text Key261734817
Report Number2438477-2021-00014
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
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 FDA05/18/2021
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