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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; WALKER,ADULT, BARIATRIC, W/WHEELS, BASIC
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MEDLINE INDUSTRIES, LP; WALKER,ADULT, BARIATRIC, W/WHEELS, BASIC Back to Search Results
Catalog Number MDS86410XWWB
Device Problem Mechanical Problem (1384)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2024
Event Type  Injury  
Manufacturer Narrative
According to the customer, when walking with the walker the "rivet popped out" causing the support bar to become detached.The customer reported he continued using the broken device and fell the "next day".The customer reported he "hit" his "head and right hip" on the wall when he fell causing a "lump" on his head.The customer reported he was recovering from a "right hip replacement".The customer reported he was advised by his physician to go to the emergency room the next day due to his "warfarin and plavix" medications.The customer reported he was in the hospital for "5 days" due to a "low hemoglobin" level.The customer reported they performed "cat scans, ultrasounds, an endoscopy, and a colonoscopy but, weren't able to find any bleeding." the customer reported the physician discontinued the warfarin and plavix from his medication list.The customer reported his "head and hip" are still "sore".The customer reported he is continuing to use the broken device.This writer advised him to not use the broken device.No additional information is available at this time.Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
Event Description
According to the customer, when walking with the walker the "rivet popped out" causing the support bar to become detached.The customer reported he continued using the broken device and fell the "next day".
 
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Type of Device
WALKER,ADULT, BARIATRIC, W/WHEELS, BASIC
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093
Manufacturer Contact
danielle tognocchi
three lakes drive
northfield, IL 60093
MDR Report Key18663612
MDR Text Key334810785
Report Number1417592-2024-00059
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 Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/07/2024
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 Catalogue NumberMDS86410XWWB
Device Lot Number88523010002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2024
Initial Date Manufacturer Received 01/10/2024
Initial Date FDA Received02/07/2024
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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