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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRIVE MEDICAL EQUIPMENT DIAMOND ALLU TOLLSYOT; DRIVE MECHANICAL WALKWAY
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DRIVE MEDICAL EQUIPMENT DIAMOND ALLU TOLLSYOT; DRIVE MECHANICAL WALKWAY Back to Search Results
Model Number 740R
Device Problems Collapse (1099); Torn Material (3024)
Patient Problems Fall (1848); Injury (2348)
Event Date 07/08/2015
Event Type  Injury  
Event Description
Defect in the folding mechanism of the drive rollator (mechanical walker.Rollator collapsed while i was walking and abruptly threw me to the marble floor.Subsequently removed from the market.Discontinued selling product.As i know no recall on the defective rollator.I tore my right rollator cuff.(i'm right handed).Eighty-two years old what chain male.Suffering from limb girdle (muscular dystrophy disease (reason for the use of the rollator)).During the first eighteen months i suffered immensely and about six months ago, (approx (b)(6) 2016) tore the other cuff (left arm).Contributing to my inability due to age etc.My doctor specifically said surgery was not an option.Currently home bound with both arms in constant pain.
 
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Brand Name
DIAMOND ALLU TOLLSYOT
Type of Device
DRIVE MECHANICAL WALKWAY
Manufacturer (Section D)
DRIVE MEDICAL EQUIPMENT
MDR Report Key6135038
MDR Text Key61246777
Report NumberMW5066381
Device Sequence Number1
Product Code ITJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 11/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Other
Device Model Number740R
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/28/2016
Type of Device Usage N
Patient Sequence Number1
Treatment
2X A DAY.; 5 MG BY MOUTH, ONCE A DAY.; AMLODIPINE; BUPROPION (WELLBUTRIN SR), 150MG, BY MOUTH, ; BY MOUTH, ONCE A DAY.; CALCIUM 630 MG, SODIUM 100 MG, BY MOUTH, TWO PER ; CARVEDILOL GENERIC PCR COREG, 25MG, BY MOUTH, ; CIALIS, 5MG, DO, DO.; CITRACAL ALCIUM CITRATE + D3, VIT D3, 500 IU, ; COQ10 200MG BY MOUTH, ONCE A DAY.; CQ 10; DAY.; DOXAZOSIN (CARDURA), 4MG, BY MOUTH, 2X A DAY; HYDROCHLOROTHIAZIDE, 25MG, BY MOUTH, 1X A DAY; LOSARTAN (COZAAR), 100MG, BY MOUTH, 1X A DAY; METRONIDAZOLE TOPICAM CREAM, 0.75 PERCENT, APPLIED; MULTI-VITAMIN (MEN'S HEALTH FORMULA), VARIOUS, ; OTC MEDS: ONE A DAY VITAMIN; PROLIA, ONCE EVERY SIX MONTHS. ; RX MEDS: WARFARIN (COUMADIN 5 MG ORAL TABLET 14.00; TO AFFECTED AREAS, ONCE A DAY.; TWICE A DAY.; VITAMIN D; VITAMIN D3, 1000 IU, BY MOUTH, TWICE A DAY.
Patient Outcome(s) Required Intervention; Disability;
Patient Age82 YR
Patient Weight79
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