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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN UNKNOWN; ROLLATOR
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UNKNOWN UNKNOWN; ROLLATOR Back to Search Results
Model Number UNKNOWN
Device Problem Collapse (1099)
Patient Problems Fall (1848); Head Injury (1879); Neck Pain (2433)
Event Date 04/07/2020
Event Type  Injury  
Event Description
It was reported that an end user was injured while using one of our rollators.The exact model and manufacturer are unknown at this time.The unit was purchased several years ago.The end user applied and locked the brakes and sat down on the seat.One of the front wheels cracked, causing her to fall backwards and hit her head on the driveway.The end user reported sustaining injuries to her tailbone, elbow, neck, scalp and thumb.The doctor ordered head and neck x-rays as well as a ct scan of her head.It was reported that the tests came back negative.The doctor instructed the end user to temporarily wear a cervical collar and apply heat as needed.
 
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Brand Name
UNKNOWN
Type of Device
ROLLATOR
Manufacturer (Section D)
UNKNOWN
CH 
MDR Report Key10014080
MDR Text Key191586525
Report Number1422443-2020-00004
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 Other
Type of Report Initial
Report Date 04/30/2020
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 NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/2020
Distributor Facility Aware Date04/09/2020
Event Location Home
Date Report to Manufacturer04/30/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight79
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