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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN DRIVE; WALKER
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UNKNOWN DRIVE; WALKER Back to Search Results
Model Number UNKNOWN
Device Problem Device Damaged Prior to Use (2284)
Patient Problems Fall (1848); Joint Dislocation (2374)
Event Date 03/01/2020
Event Type  Injury  
Event Description
Drive devilbiss healthcare is the initial importer of the device which is a walker.We are awaiting return of the walker for evaluation.Consumer did not provide model or serial number for the unit.We are filing this report in an overabundance of caution and desire to remain timely.End-user noted that the walker was being used to address a dislocated right hip.He reported that on (b)(6) 2020 while using the walker to enter his home from the garage, one of the legs of the walker collapsed.He fell and reportedly dislocated his right hip.He was transported to the hospital where they reset his artificial hip.He was discharged with instructions to do exercises for the next 6 months and avoid certain activities which could cause a recurrence of the dislocation.End-user noted that a pin had been missing in the unit from use.
 
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Brand Name
DRIVE
Type of Device
WALKER
Manufacturer (Section D)
UNKNOWN
MDR Report Key10082419
MDR Text Key194812645
Report Number2438477-2020-00030
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 05/22/2020
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/22/2020
Distributor Facility Aware Date04/22/2020
Event Location Home
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
Patient Weight77
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