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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONSMA RED ADULT ROLLATOR WITH BASKET 9153647190; WALKER, MECHANICAL

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CONSMA RED ADULT ROLLATOR WITH BASKET 9153647190; WALKER, MECHANICAL Back to Search Results
Model Number 65851R
Device Problem Crack (1135)
Patient Problem Discomfort (2330)
Event Type  Injury  
Event Description
Dealer stated that the end users son reported that the seat on his mothers 65851r rollator has been cracked for some time and has pinched his mothers bottom.
 
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Brand Name
RED ADULT ROLLATOR WITH BASKET 9153647190
Type of Device
WALKER, MECHANICAL
Manufacturer (Section D)
CONSMA
no. 158 huicheng rd
huimin ind
jianshan zhejiang
CH 
MDR Report Key4383672
MDR Text Key19353704
Report Number1531186-2015-00013
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
Source Type Invalid Data
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 01/05/2015,12/26/2014
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 Number65851R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/05/2015
Distributor Facility Aware Date12/26/2014
Device Age2 YR
Date Report to Manufacturer01/05/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/06/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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