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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO. DRIVE; ROLLATOR
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HEBEI HEALTHPLUS MEDICAL DEVICE CO. DRIVE; ROLLATOR Back to Search Results
Model Number 301PSBN
Device Problems Device Tipped Over (2589); Device Dislodged or Dislocated (2923)
Patient Problem Bone Fracture(s) (1870)
Event Date 09/05/2017
Event Type  Injury  
Event Description
Drive devilbiss healthcare is the initial importer of the device involved in this incident.This device is a rollator.The end user locked the wheel locks and went to sit down when the caster came out of the threading and the unit tipped over.She did not seek medical attention until four (4) days later.She was diagnosed with broken ribs at the urgent care center.We have received images of rollator but it has not been returned.We will continue to request return of the device so we can have it reviewed.
 
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Brand Name
DRIVE
Type of Device
ROLLATOR
Manufacturer (Section D)
HEBEI HEALTHPLUS MEDICAL DEVICE CO.
no. 1, chuangye street
southwest indust matou
ecological industry park, handan city 05604 6
CH  056046
MDR Report Key7042428
MDR Text Key92458646
Report Number2438477-2017-00085
Device Sequence Number1
Product Code ITJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 11/17/2017,10/02/2017
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
Device Operator Lay User/Patient
Device Model Number301PSBN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/17/2017
Distributor Facility Aware Date10/06/2017
Device Age14 MO
Event Location Nursing Home
Date Report to Manufacturer11/17/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/17/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age95 YR
Patient Weight57
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