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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: A & I INDUSTRIES LTD DRIVE; ROLLATOR
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A & I INDUSTRIES LTD DRIVE; ROLLATOR Back to Search Results
Model Number RTL10266RD
Device Problem Folded (2630)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)
Event Date 12/06/2017
Event Type  Injury  
Event Description
(b)(6) is the initial importer of the device which is a rollator.Our pms associates are awaiting confirmation medical documents and return of the product for evaluation.Customer is using product due to spinal injuries and fibromialga.End-user was walking with the aid of the device in the downtown area.She turned but reported that the rollator continued to go straight and folded.She fell and twisted her back.She went to the er and was diagnosed with a hairline fracture.She is hospitalized and is currently receiving treatment.
 
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Brand Name
DRIVE
Type of Device
ROLLATOR
Manufacturer (Section D)
A & I INDUSTRIES LTD
lian du industry park
le liu town
shunde district foshan city, guangdong
CH 
MDR Report Key7525832
MDR Text Key108641028
Report Number2438477-2018-00028
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 05/18/2018
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 NumberRTL10266RD
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/18/2018
Distributor Facility Aware Date03/01/2018
Device Age26 MO
Event Location Other
Date Report to Manufacturer05/22/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age53 YR
Patient Weight100
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