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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS CO., LTD DRIVE MEDICAL; ROLLATOR
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GENTEEL HOMECARE PRODUCTS CO., LTD DRIVE MEDICAL; ROLLATOR Back to Search Results
Model Number 745R
Device Problem Misassembled (1398)
Patient Problem Injury (2348)
Event Date 05/12/2016
Event Type  Injury  
Event Description
(b)(4) received a notice of incident from (b)(6) which involved a rollator that (b)(4) imports and distributes.As the end user walked in the rain with the rollator, she stepped on a pothole which she did not noticed as it was filled and covered with water.Her left foot and one of the rear casters both went into the hole which ended up for her to scraped her left leg with the bolts of the caster.The leg became infected for which an antibiotic was prescribed for her.This information was based on the report of the end user.
 
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Brand Name
DRIVE MEDICAL
Type of Device
ROLLATOR
Manufacturer (Section D)
GENTEEL HOMECARE PRODUCTS CO., LTD
liyu industry area
danzao, nanhai
foshan, guangdong 52821 6
CH  528216
MDR Report Key5732539
MDR Text Key47624943
Report Number2438477-2016-00026
Device Sequence Number1
Product Code ITJ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Patient
Type of Report Initial
Report Date 06/17/2016,05/18/2016
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 Number745R
Device Catalogue Number745R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/17/2016
Device Age6 YR
Event Location Other
Date Report to Manufacturer06/17/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/17/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
Patient Weight57
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