MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; WALKER,ADULT,EX WIDE,5IN WHEELS

Catalog Number MDS86410XWW

Device Problem Collapse (1099)

Patient Problems Fall (1848); Injury (2348)

Event Date 07/18/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that, while walking the walker "collapsed," and the end-user experienced a fall in his hallway on carpet.End-user called 911, paramedic's removed/assisted end user off the ground and transported him to the local emergency department (ed).End user reports, "regular and pelvic cat scan were taken, along with x-rays, and lab work.No further diagnostic exams were reported to the manufacturer.End user was admitted to the hospital, under the diagnosis of "blood in the urine." end-user reports he was treated with intravenous (iv) dilaudid for pain control while in the hospital.End user state's he signed himself out of the hospital the next day (b)(6) 2020, against medical advice "ama," "because the hospital refused to give him his regular medications.I.E.Heart medication." end user reports upon leaving the hospital no new pain medications were prescribed to him.End user reports he already "had pain medication oxycontin, oxycodone, and cyclobenzaprine from a prior injury." but would not elaborate.The end-user reports he has "home physical therapy a couple times a week due to back pain caused by the fall." the sample is not available for evaluation.No further information is available at this time.Due to the reported need for medical intervention, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the walker "collapsed," and the end-user experienced a fall resulting in a hospital admission.

• Type of Device: WALKER,ADULT,EX WIDE,5IN WHEELS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 10393355
• MDR Text Key: 202532309
• Report Number: 1417592-2020-00086
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86410XWW
• Device Lot Number: 65519100004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 149