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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 Break (1069)
Patient Problems Bruise/Contusion (1754); Fall (1848); Skin Tears (2516)
Event Type  Injury  
Event Description
End user went to sit down on the rollator and the front right wheel broke causing the end user to fall over.He was hurt bruised head to toe, hit his head, left hip bruised, left arm cuts and bruising, right arm deep scratch like a scrape and ribs hurt.Went to hospital and they did a cat scan and found no breaks.No serial # or model number.Only lot #cgb20120108708, registry (b)(4) (cn).End user was given a rollator from (b)(6) about 2 years ago.Curved back bar, red, 8" wheels possibly ((mrt-413-a-r-maybe).Advised to stop using the broken rollator immediately.
 
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Brand Name
UNKNOWN
Type of Device
ROLLATOR
Manufacturer (Section D)
UNKNOWN
MDR Report Key5101721
MDR Text Key26717205
Report Number3005182235-2015-00008
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
Report Date 09/24/2015
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? Yes
Device Operator Lay User/Patient
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/24/2015
Distributor Facility Aware Date08/26/2015
Event Location Home
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/24/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age90 YR
Patient Weight94
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